Trial Outcomes & Findings for A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure (NCT NCT04252287)
NCT ID: NCT04252287
Last Updated: 2025-03-30
Results Overview
Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
476 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2025-03-30
Participant Flow
A total of 1,333 participants were screened. Of which, 476 participants were randomized in the study.
Participant milestones
| Measure |
Placebo
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
238
|
238
|
|
Overall Study
Treated (Safety Analysis Set)
|
231
|
224
|
|
Overall Study
COMPLETED
|
207
|
209
|
|
Overall Study
NOT COMPLETED
|
31
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Overall Study
Death
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
16
|
|
Overall Study
Protocol Violation
|
3
|
4
|
Baseline Characteristics
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Baseline characteristics by cohort
| Measure |
Placebo
n=231 Participants
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=224 Participants
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 13.5 • n=93 Participants
|
62.9 Years
STANDARD_DEVIATION 13.15 • n=4 Participants
|
63.4 Years
STANDARD_DEVIATION 13.32 • n=27 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
251 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
199 Participants
n=93 Participants
|
184 Participants
n=4 Participants
|
383 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set (FAS) included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Change from baseline in KCCQ-TSS was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-TSS was average of domains- symptom frequency and symptom burden, and transformed to a single score which ranged from 0 (worst) to 100 (the best possible status), where the higher score reflected better health status.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=208 Participants
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 12
|
4.9 Score on a scale
Standard Error 1.27
|
9.2 Score on a scale
Standard Error 1.27
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluated for this outcome measure.
Change from baseline in total daily step count at Week 12 was reported in this outcome measure. The number of steps taken per day was measured using a step activity monitor at baseline and throughout the study. Step count was measured from the Fitbit device data. The Fitbit app on the participant's phone collected all data from the Fitbit device. A negative change from baseline indicated a decrease in the number of daily steps.
Outcome measures
| Measure |
Placebo
n=208 Participants
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=205 Participants
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Total Daily Step Count at Week 12
|
-74.9 Daily step count
Standard Error 112.85
|
-45.1 Daily step count
Standard Error 113.78
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants with available data for each specified category.
Change from baseline in KCCQ physical limitation score and KCCQ quality of life score were reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 (worst) and 100 (the best possible status), where the higher score reflected better health status.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=208 Participants
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12
KCCQ-Physical Limitation
|
4.8 Score on a scale
Standard Error 1.26
|
7.8 Score on a scale
Standard Error 1.27
|
|
Change From Baseline in KCCQ Individual Domain Scores (Physical Limitation and Quality of Life) at Week 12
KCCQ-Quality of Life
|
9.1 Score on a scale
Standard Error 1.40
|
12.4 Score on a scale
Standard Error 1.41
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Change from baseline in KCCQ-clinical summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=208 Participants
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in KCCQ Clinical Summary Score at Week 12
|
4.7 Score on a scale
Standard Error 1.16
|
8.5 Score on a scale
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all randomized participants who had received at least one dose of study intervention/medication and had at least one post-baseline KCCQ measurement. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Outcome measures
| Measure |
Placebo
n=206 Participants
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=208 Participants
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Change From Baseline in KCCQ Overall Summary Score at Week 12
|
6.2 Score on a scale
Standard Error 1.18
|
9.5 Score on a scale
Standard Error 1.18
|
Adverse Events
Placebo
Serious events: 36 serious events
Other events: 0 other events
Deaths: 5 deaths
Canagliflozin 100 mg
Serious events: 33 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Placebo
n=231 participants at risk
Participants received placebo (matched to canagliflozin) capsule orally once daily for 12 weeks.
|
Canagliflozin 100 mg
n=224 participants at risk
Participants received canagliflozin 100 milligrams (mg) immediate-release, over-encapsulated tablet (as capsule) orally once daily for 12 weeks.
|
|---|---|---|
|
Investigations
Oxygen saturation decreased
|
0.87%
2/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Weight increased
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Arrhythmia
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.87%
2/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.89%
2/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac arrest
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
3/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
1.8%
4/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Pericardial effusion
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Endocrine disorders
Goitre
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Eye disorders
Visual impairment
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest pain
|
0.87%
2/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Oedema
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Pain
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Peripheral swelling
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.89%
2/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Sudden cardiac death
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.87%
2/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
1.8%
4/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.87%
2/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.89%
2/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood glucose increased
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Heart rate increased
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Balance disorder
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Bell's palsy
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.89%
2/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Psychiatric disorders
Hallucination
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Renal impairment
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
3/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Surgical and medical procedures
Cardiac operation
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.43%
1/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Hypotension
|
0.87%
2/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/231 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
0.45%
1/224 • All-cause mortality: Up to 9 months; serious adverse events and other adverse events: Up to 30 days after end of treatment (up to 4 months)
Safety analysis set included all randomized participants who received at least 1 dose of study intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
Director CVM Health Equity
Janssen Scientific Affairs, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER