Trial Outcomes & Findings for A Study of Baricitinib in Participants With Rheumatoid Arthritis (NCT NCT04086745)
NCT ID: NCT04086745
Last Updated: 2026-07-10
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
1050 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
2026-07-10
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
|
352
|
350
|
348
|
|
Overall Study
Safety Analysis Set
|
340
|
333
|
327
|
|
Overall Study
Pooled Analysis Set
|
1219
|
1214
|
1207
|
|
Overall Study
COMPLETED
|
138
|
155
|
151
|
|
Overall Study
NOT COMPLETED
|
214
|
195
|
197
|
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
|
20
|
29
|
21
|
|
Overall Study
Death
|
6
|
6
|
5
|
|
Overall Study
Protocol deviation
|
16
|
15
|
14
|
|
Overall Study
Withdrawal by Subject
|
76
|
84
|
69
|
|
Overall Study
Physician Decision
|
18
|
11
|
21
|
|
Overall Study
Lack of Efficacy
|
32
|
15
|
25
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Participants who were unable to attend their final study visit
|
3
|
1
|
3
|
|
Overall Study
Site Terminated By Sponsor
|
3
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
29
|
26
|
19
|
|
Overall Study
Other
|
10
|
7
|
18
|
Baseline Characteristics
A Study of Baricitinib in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Baricitinib 2mg
n=340 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=333 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=327 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=1000 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.90 years
STANDARD_DEVIATION 11.52 • n=9 Participants
|
60.80 years
STANDARD_DEVIATION 11.27 • n=27 Participants
|
61.20 years
STANDARD_DEVIATION 10.90 • n=267 Participants
|
60.60 years
STANDARD_DEVIATION 11.24 • n=265 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=9 Participants
|
259 Participants
n=27 Participants
|
248 Participants
n=267 Participants
|
765 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=9 Participants
|
74 Participants
n=27 Participants
|
79 Participants
n=267 Participants
|
235 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=9 Participants
|
80 Participants
n=27 Participants
|
61 Participants
n=267 Participants
|
210 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
264 Participants
n=9 Participants
|
245 Participants
n=27 Participants
|
257 Participants
n=267 Participants
|
766 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
24 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=9 Participants
|
33 Participants
n=27 Participants
|
38 Participants
n=267 Participants
|
112 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
287 Participants
n=9 Participants
|
286 Participants
n=27 Participants
|
275 Participants
n=267 Participants
|
848 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
12 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
340 Participants
n=9 Participants
|
333 Participants
n=27 Participants
|
327 Participants
n=267 Participants
|
1000 Participants
n=265 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 |
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=2433 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
TNF Inhibitor
n=1214 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=1219 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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 |
TNF Inhibitor
n=1214 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=1219 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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 |
TNF Inhibitor
n=1214 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=1219 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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 |
TNF Inhibitor
n=1214 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=1219 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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 |
TNF Inhibitor
n=1214 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=1219 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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 |
TNF Inhibitor
n=1214 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=1219 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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 JAJD (NCT04086745) and study JAJA (NCT03915964) 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 5.3 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 |
TNF Inhibitor
n=333 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF Inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 2/4 mg
n=340 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the baricitinib 2mg or 4mg treatment arms and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=673 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=327 Participants
Participants from the current study JAJD (NCT04086745) and study JAJA (NCT03915964) 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
|
648.5 patient-years
|
622.7 patient-years
|
1289.6 patient-years
|
672.0 patient-years
|
Adverse Events
TNF Inhibitor
Serious events: 68 serious events
Other events: 35 other events
Deaths: 5 deaths
Baricitinib 2mg
Serious events: 78 serious events
Other events: 30 other events
Deaths: 6 deaths
Baricitinib 4mg
Serious events: 79 serious events
Other events: 28 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
TNF Inhibitor
n=327 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.
|
Baricitinib 2mg
n=340 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=333 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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Anaemia macrocytic
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Blood loss anaemia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Leukocytosis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Leukopenia
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Lymphadenopathy
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Thrombocytopenia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Thrombocytopenic purpura
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 left ventricular failure
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.92%
3/327 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Arrhythmia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Heart failure with reduced ejection fraction
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 incompetence
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
4/333 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Palpitations
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pericardial effusion
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pericarditis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Tachycardia
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Choroidal effusion
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 artery occlusion
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 adhesions
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Ascites
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 ulcerative
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Duodenitis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Enteritis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 disorder
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Haemorrhoidal haemorrhage
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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, obstructive
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 paralytic
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Malignant ascites
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Melaena
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 mass
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Peptic ulcer
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Terminal ileitis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Vomiting
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Incarcerated hernia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
1.2%
4/327 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Oedema peripheral
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Peripheral swelling
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Abdominal abscess
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Bursitis infective
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
1.2%
4/327 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 colitis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.92%
3/327 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
8/340 • Number of events 8 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.7%
9/333 • Number of events 9 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Cystitis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Cytomegalovirus infection
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Encephalitis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Gangrene
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 oticus
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Human anaplasmosis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Klebsiella sepsis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Liver abscess
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Metapneumovirus infection
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Necrotising fasciitis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Oral candidiasis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Orbital infection
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pelvic abscess
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pharyngitis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
2.1%
7/327 • Number of events 10 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.9%
10/340 • Number of events 11 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.7%
9/333 • Number of events 11 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 respiratory syncytial viral
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 viral
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pseudomonas infection
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.92%
3/327 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.92%
3/327 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
4/340 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
4/333 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Tubo-ovarian abscess
|
0.00%
0/248 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.39%
1/258 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/259 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
4/333 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Urosepsis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Anaesthetic complication
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Concussion
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Craniofacial fracture
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.90%
3/333 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Maternal exposure during pregnancy
|
0.00%
0/248 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.39%
1/258 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/259 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 complication
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Postoperative ileus
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Oxygen saturation decreased
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 ketoacidosis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Hyperglycaemia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Hyperkalaemia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Hypoglycaemia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Cervical spinal stenosis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Musculoskeletal chest pain
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Osteoporosis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Polyarthritis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Rhabdomyolysis
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 lateral recess stenosis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 metastatic
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 stage i
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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)
Cervix carcinoma stage iii
|
0.40%
1/248 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/258 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/259 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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)
Cholangiocarcinoma
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 stage iv
|
0.00%
0/248 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.39%
1/258 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/259 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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)
Hepatobiliary cancer
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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)
Huerthle cell carcinoma
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 iv
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 squamous cell carcinoma
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/79 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
2/82 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.7%
2/74 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 ii
|
0.00%
0/79 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/82 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
1/74 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 metastatic
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 perivascular epithelioid cell tumour
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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)
Small cell lung cancer metastatic
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 skin
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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)
Transitional cell cancer of renal pelvis and ureter metastatic
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/248 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/258 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.39%
1/259 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Aphasia
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 artery stenosis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Generalised tonic-clonic seizure
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Haemorrhage intracranial
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Lumbar radiculopathy
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Migraine
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Optic neuritis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 claudication
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 cord compression
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.59%
2/340 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Toxic encephalopathy
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 loosening
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Mania
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Mental status changes
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
6/340 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
1.2%
4/327 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Hypoxia
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Idiopathic pulmonary fibrosis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.60%
2/333 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pleural effusion
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Pneumothorax
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
1.2%
4/327 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
4/340 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.90%
3/333 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Blister infected
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Diabetic foot
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Hidradenitis
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.61%
2/327 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Arterial haemorrhage
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
1.5%
5/327 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.88%
3/340 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
4/333 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 venous
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
Hypotension
|
0.31%
1/327 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 vascular haematoma
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/340 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.30%
1/333 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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
|
0.00%
0/327 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.29%
1/340 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/333 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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 |
TNF Inhibitor
n=327 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.
|
Baricitinib 2mg
n=340 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=333 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.
|
|---|---|---|---|
|
Infections and infestations
Covid-19
|
10.7%
35/327 • Number of events 37 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
30/340 • Number of events 35 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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%
28/333 • Number of events 32 • From the time of the informed consent signature up to the last study visit (approximately up to 5.3 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have 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