Trial Outcomes & Findings for Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer (NCT NCT01958021)
NCT ID: NCT01958021
Last Updated: 2025-03-07
Results Overview
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression.PFS was assessed by investigator assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
668 participants
Primary outcome timeframe
Up to 23 months
Results posted on
2025-03-07
Participant Flow
Participants were enrolled in 223 sites across 29 countries.
Screening assessments were conducted up to 21 days prior to the randomization
Participant milestones
| Measure |
Ribociclib + Letrozole
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Treatment
STARTED
|
334
|
334
|
|
Treatment
Treated
|
334
|
330
|
|
Treatment
Crossover Cohort
|
0
|
4
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
334
|
334
|
|
Post-treatment Efficacy Follow-up
STARTED
|
26
|
9
|
|
Post-treatment Efficacy Follow-up
COMPLETED
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
NOT COMPLETED
|
25
|
9
|
Reasons for withdrawal
| Measure |
Ribociclib + Letrozole
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Treatment
Progressive disease
|
206
|
265
|
|
Treatment
Adverse Event
|
38
|
10
|
|
Treatment
Subject/guardian decision
|
29
|
25
|
|
Treatment
Physician Decision
|
28
|
21
|
|
Treatment
Death
|
6
|
1
|
|
Treatment
Protocol deviation
|
3
|
1
|
|
Treatment
Sponsor decision
|
24
|
11
|
|
Post-treatment Efficacy Follow-up
Adverse Event
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
Death
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
Lost to Follow-up
|
1
|
0
|
|
Post-treatment Efficacy Follow-up
Physician Decision
|
1
|
2
|
|
Post-treatment Efficacy Follow-up
Progressive disease
|
12
|
3
|
|
Post-treatment Efficacy Follow-up
Sponsor decision
|
5
|
2
|
|
Post-treatment Efficacy Follow-up
Subject/Guardian decision
|
4
|
2
|
Baseline Characteristics
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
Total
n=668 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 10.52 • n=7 Participants
|
61.6 Years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
334 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
269 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
549 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 23 monthsPopulation: Full Analysis Set (FAS) including all randomized participants
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression.PFS was assessed by investigator assessment according to RECIST 1.1. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Progression Free Survival (PFS) by Investigator Assessment
|
NA months
Interval 19.3 to
NA = not estimable due to the insufficient number of participants with events
|
14.7 months
Interval 13.0 to 16.5
|
SECONDARY outcome
Timeframe: Up to approximately 87 monthsPopulation: FAS including all randomized participants
OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status.OS was estimated using the Kaplan-Meier method. As per protocol, the final OS analysis was conducted after approximately 400 deaths were documented. The median OS, along with 95% confidence intervals, was reported for each treatment group.The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI.
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Overall Survival (OS)
|
63.9 Months
Interval 52.4 to 71.0
|
51.4 Months
Interval 47.2 to 59.7
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: FAS including all randomized participants
ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per investigator assessment. . CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Overall Response Rate (ORR) by Investigator Assessment
|
40.7 Percentage of participants
Interval 35.4 to 46.0
|
27.5 Percentage of participants
Interval 22.8 to 32.3
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: FAS including all randomized participants
Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 as per investigator assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Clinical Benefit Rate (CBR) by Investigator Assessment
|
79.6 Percentage of participants
Interval 75.3 to 84.0
|
72.8 Percentage of participants
Interval 68.0 to 77.5
|
SECONDARY outcome
Timeframe: From baseline up to 23 monthsPopulation: FAS including all randomized participants
ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score
|
22.6 Months
Interval 22.6 to
NA= Not estimable due to the insufficient number of participants with events
|
NA Months
NA= Not estimable due to the insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From baseline up to 23 monthsPopulation: FAS including all randomized participants
The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
|
19.3 Months
Interval 16.6 to 22.1
|
NA Months
Interval 14.8 to
NA= Not estimable due to the insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline, every 2 cycles for 18 months, then every 3 cycles until last dose; at EOT (within 15 days from last dose);every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to 23 months. Cycle=28 daysPopulation: Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.
The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assesed. A positive change from baseline indicated improvement. For subjects who discontinued treatment earlier and without disease progression, post-treatment efficacy follow-up visits occurred every 8 weeks after End of treatment (EOT) during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression or end of study.
Outcome measures
| Measure |
Ribociclib + Letrozole
n=285 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=285 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 9 Day 1
|
5.1 Score on a Scale
Standard Deviation 21.95
|
8.0 Score on a Scale
Standard Deviation 20.49
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 22 Day 1
|
4.8 Score on a Scale
Standard Deviation 20.09
|
12.5 Score on a Scale
Standard Deviation 14.15
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 25 Day 1
|
-8.3 Score on a Scale
Standard Deviation 8.33
|
—
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
EOT
|
-1.2 Score on a Scale
Standard Deviation 20.97
|
-1.2 Score on a Scale
Standard Deviation 15.30
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 3 Day 1
|
2.9 Score on a Scale
Standard Deviation 18.68
|
4.9 Score on a Scale
Standard Deviation 19.14
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 5 Day 1
|
4.6 Score on a Scale
Standard Deviation 19.86
|
6.8 Score on a Scale
Standard Deviation 19.64
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 7 Day 1
|
4.6 Score on a Scale
Standard Deviation 20.96
|
6.0 Score on a Scale
Standard Deviation 20.19
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 11 Day 1
|
4.9 Score on a Scale
Standard Deviation 21.11
|
7.0 Score on a Scale
Standard Deviation 20.45
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 13 Day 1
|
5.3 Score on a Scale
Standard Deviation 22.37
|
6.5 Score on a Scale
Standard Deviation 20.40
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 15 Day 1
|
5.5 Score on a Scale
Standard Deviation 21.43
|
8.7 Score on a Scale
Standard Deviation 21.23
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 17 Day 1
|
4.6 Score on a Scale
Standard Deviation 22.85
|
7.4 Score on a Scale
Standard Deviation 21.75
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Cycle 19 Day 1
|
5.0 Score on a Scale
Standard Deviation 23.08
|
7.7 Score on a Scale
Standard Deviation 18.81
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 1
|
8.3 Score on a Scale
Standard Deviation 28.87
|
-16.7 Score on a Scale
Standard Deviation 16.67
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 2
|
3.6 Score on a Scale
Standard Deviation 17.25
|
-20.8 Score on a Scale
Standard Deviation 17.68
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 3
|
5.0 Score on a Scale
Standard Deviation 21.73
|
-12.5 Score on a Scale
Standard Deviation 5.89
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 4
|
6.3 Score on a Scale
Standard Deviation 28.36
|
8.3 Score on a Scale
Standard Deviation 0.00
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 5
|
0.0 Score on a Scale
Standard Deviation 28.87
|
-4.2 Score on a Scale
Standard Deviation 5.89
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 6
|
20.8 Score on a Scale
Standard Deviation 41.25
|
—
|
|
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Post -treatment efficacy visit 7
|
50.0 Score on a Scale
|
—
|
POST_HOC outcome
Timeframe: Pre-treatment: Up to 21 days. On-treatment: Up to 99 months. Crossover on-treatment: Up to 12 months after crossing-over.Post-treatment survival FU: Up to 99 months.Crossover post-treatment survival FU: Up to 12 months after crossing-overPopulation: FAS including all randomized participants
Pre-treatment deaths were collected from randomization to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment survival follow-up (FU) deaths were collected from day 31 after last dose of study treatment to end of study. Crossover post-treatment survival FU deaths were collected from day 31 after last dose of crossover treatment to end of study
Outcome measures
| Measure |
Ribociclib + Letrozole
n=334 Participants
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
|
Placebo + Letrozole
n=334 Participants
Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral.
Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
|
|---|---|---|
|
All Collected Deaths
On-treatment
|
8 Participants
|
3 Participants
|
|
All Collected Deaths
Pre-treatment
|
0 Participants
|
0 Participants
|
|
All Collected Deaths
Crossover On-treatment
|
—
|
0 Participants
|
|
All Collected Deaths
Post-treatment survival follow-up
|
178 Participants
|
218 Participants
|
|
All Collected Deaths
Crossover post-treatment survival follow-up
|
—
|
0 Participants
|
|
All Collected Deaths
All deaths
|
186 Participants
|
221 Participants
|
Adverse Events
Ribociclib + Letrozole
Serious events: 108 serious events
Other events: 331 other events
Deaths: 8 deaths
Placebo + Letrozole
Serious events: 62 serious events
Other events: 317 other events
Deaths: 3 deaths
Crossover to Ribociclib + Letrozole
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Ribociclib + Letrozole (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 178 deaths
Placebo + Letrozole (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 218 deaths
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ribociclib + Letrozole
n=334 participants at risk
All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.
|
Placebo + Letrozole
n=330 participants at risk
All-cause mortality from randomization until 30 days after last dose or start of crossover treatment. Adverse Events from first dose until 30 days after last dose or start of crossover treatment.
|
Crossover to Ribociclib + Letrozole
n=4 participants at risk
All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment
|
Ribociclib + Letrozole (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
|
Placebo + Letrozole (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
|
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose of crossover treatment). No AEs were collected during this period
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
4/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Arrhythmia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiac failure congestive
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cardiomyopathy
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Sinus bradycardia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Cataract
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Glaucoma
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
6/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Ascites
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Colitis
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
1.2%
4/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Haematemesis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
1.5%
5/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
5/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Asthenia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Chest discomfort
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
General physical health deterioration
|
1.5%
5/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Malaise
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Non-cardiac chest pain
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Sudden death
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hepatic failure
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Abdominal infection
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Abscess jaw
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Atypical pneumonia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Bronchitis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Bronchitis viral
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Cellulitis
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Clostridium difficile infection
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Encephalitis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Erysipelas
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Osteomyelitis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pneumonia
|
2.4%
8/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Sepsis
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Urosepsis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Wound infection
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Overdose
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
4/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Blood bilirubin increased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Blood creatinine increased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
C-reactive protein increased
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Electrocardiogram QT prolonged
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
International normalised ratio increased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Lymphocyte count decreased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Neutrophil count decreased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Waist circumference increased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Weight decreased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
White blood cell count decreased
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
4/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Depressed level of consciousness
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Dizziness
|
1.5%
5/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Ischaemic stroke
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Migraine
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Presyncope
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Spinal cord compression
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Syncope
|
1.2%
4/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Confusional state
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Major depression
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Mental status changes
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Hydronephrosis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Renal colic
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Renal failure
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
7/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.90%
3/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.2%
4/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
4/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.61%
2/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Embolism
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypotension
|
0.60%
2/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Orthostatic hypotension
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Superior vena cava syndrome
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
Other adverse events
| Measure |
Ribociclib + Letrozole
n=334 participants at risk
All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose.
|
Placebo + Letrozole
n=330 participants at risk
All-cause mortality from randomization until 30 days after last dose or start of crossover treatment. Adverse Events from first dose until 30 days after last dose or start of crossover treatment.
|
Crossover to Ribociclib + Letrozole
n=4 participants at risk
All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment
|
Ribociclib + Letrozole (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
|
Placebo + Letrozole (Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period
|
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Survival Follow-up)
Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose of crossover treatment). No AEs were collected during this period
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
77/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.3%
24/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
50.0%
2/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.8%
56/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.0%
10/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
50.0%
2/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.7%
19/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.1%
7/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.3%
218/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
5.5%
18/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
50.0%
2/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.2%
24/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
8.1%
27/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.1%
7/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Dry eye
|
8.1%
27/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.9%
13/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Lacrimation increased
|
11.7%
39/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.1%
7/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Eye disorders
Vision blurred
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.7%
9/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
41/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
10.0%
33/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.3%
31/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
6.4%
21/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
29.6%
99/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
22.7%
75/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
41.0%
137/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
26.7%
88/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
50.0%
2/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dry mouth
|
14.4%
48/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
11.2%
37/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
37/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.6%
25/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
54.8%
183/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
32.1%
106/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
75.0%
3/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Stomatitis
|
15.9%
53/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.3%
24/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Toothache
|
5.4%
18/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
4.2%
14/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
34.4%
115/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
18.8%
62/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Asthenia
|
14.7%
49/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
14.8%
49/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Chest discomfort
|
0.30%
1/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.2%
4/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Chills
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.3%
11/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Fatigue
|
43.4%
145/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
36.1%
119/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Influenza like illness
|
6.9%
23/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.0%
23/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Non-cardiac chest pain
|
5.4%
18/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.8%
29/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Oedema peripheral
|
14.7%
49/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
12.4%
41/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
General disorders
Pyrexia
|
14.7%
49/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.3%
24/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Bronchitis
|
7.5%
25/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
5.5%
18/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Conjunctivitis
|
5.4%
18/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.5%
5/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Influenza
|
7.8%
26/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
5.5%
18/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
37/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.8%
29/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Sinusitis
|
6.6%
22/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
4.8%
16/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
15.3%
51/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
13.0%
43/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
15.9%
53/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
11.2%
37/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
19.8%
66/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
6.4%
21/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
19.8%
66/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.0%
23/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
6.6%
22/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
6.4%
21/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Blood creatinine increased
|
11.1%
37/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.7%
9/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Electrocardiogram QT prolonged
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.5%
5/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Lymphocyte count decreased
|
7.8%
26/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Neutrophil count decreased
|
23.4%
78/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.5%
5/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
50.0%
2/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Platelet count decreased
|
3.3%
11/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
Weight decreased
|
8.7%
29/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
4.8%
16/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Investigations
White blood cell count decreased
|
21.0%
70/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.4%
8/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
74/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
18.5%
61/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.6%
12/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.0%
10/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.7%
29/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.6%
25/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
5.2%
17/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.3%
21/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.8%
6/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
25/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.3%
11/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.0%
10/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.1%
7/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.7%
9/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.91%
3/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
40.4%
135/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
41.2%
136/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.2%
91/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
23.0%
76/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.2%
44/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
14.2%
47/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.8%
26/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.5%
28/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.3%
21/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.2%
27/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
15/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
5.2%
17/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
35/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
9.1%
30/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.0%
20/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
6.4%
21/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.6%
62/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
19.1%
63/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Dizziness
|
16.2%
54/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
16.1%
53/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Dysgeusia
|
6.0%
20/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
4.2%
14/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Headache
|
29.3%
98/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
23.0%
76/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.9%
13/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Nervous system disorders
Taste disorder
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
2.4%
8/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Anxiety
|
12.3%
41/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.8%
29/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Depression
|
9.9%
33/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.8%
29/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Psychiatric disorders
Insomnia
|
16.5%
55/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
14.8%
49/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Breast pain
|
6.3%
21/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
7.0%
23/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.4%
8/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
4.8%
16/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.6%
89/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.2%
83/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.4%
48/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
13.3%
44/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
17/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.0%
10/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.2%
24/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
6.4%
21/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.6%
119/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
16.7%
55/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.2%
34/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
3.6%
12/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.9%
23/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
1.8%
6/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.3%
61/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
8.2%
27/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.4%
68/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
10.0%
33/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
5/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.30%
1/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
1.8%
6/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
25.0%
1/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hot flush
|
25.1%
84/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
26.7%
88/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
|
Vascular disorders
Hypertension
|
21.3%
71/334 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
20.9%
69/330 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
0.00%
0/4 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
—
0/0 • All-cause mortality (ACM): from randomization up to 99 months, including post-treatment survival follow-up (FU). If crossover, ACM also collected from start of crossover treatment to 12 months, including post-treatment survival FU. Serious and Other Adverse Events (AEs): from 1st dose of treatment to 30 days after last dose (or start of crossover treatment), up to 99 months. If crossover, AEs also collected from start of crossover treatment to 30 days post-crossover treatment, up to 12 months
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs. Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER