Trial Outcomes & Findings for A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma (NCT NCT05505734)
NCT ID: NCT05505734
Last Updated: 2025-08-03
Results Overview
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2516 participants
Primary outcome timeframe
From treatment initiation until the earliest occurrence of study completion, treatment discontinuation, step-up in maintenance therapy, or interim analysis DCO, up to one year following treatment initiation.
Results posted on
2025-08-03
Participant Flow
The first participant was screened on 2 September 2022. Participants were enrolled at 54 sites in the United States. Primary and first secondary objectives were tested at the interim analysis, on data collected up to 22 April 2024. Following the decision to stop the study early for overwhelming efficacy, participants were instructed to attend their end of study visits. The last participant last visit occurred on 22 August 2024 and final database lock was achieved on 20 September 2024.
A total of 5,221 participants were screened for this study, of which 2,516 participants were randomized to treatment; 2,705 were ineligible for participation in the trial. Of the 2,516 participants randomized, the full analysis set (ages 12 years and above) comprised of 2,421 participants as 95 participants discontinued the study prior to dosing randomized treatment.
Participant milestones
| Measure |
BDA MDI (PT027) 160/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Overall Study
STARTED
|
1257
|
1259
|
|
Overall Study
Full Analysis Set; >=12 Years
|
1209
|
1212
|
|
Overall Study
Full Analysis Set; >=18 Years
|
1180
|
1173
|
|
Overall Study
COMPLETED
|
903
|
894
|
|
Overall Study
NOT COMPLETED
|
354
|
365
|
Reasons for withdrawal
| Measure |
BDA MDI (PT027) 160/180 μg
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
51
|
64
|
|
Overall Study
Adverse Event
|
6
|
20
|
|
Overall Study
Protocol Violation
|
8
|
15
|
|
Overall Study
Lack of therapeutic response
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
247
|
237
|
|
Overall Study
Physician Decision
|
22
|
13
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Withdrawal by parent/guardian
|
0
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Other
|
17
|
13
|
Baseline Characteristics
A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
Baseline characteristics by cohort
| Measure |
BDA MDI (PT027) 160/180 μg
n=1209 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1212 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
Total
n=2421 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
29 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1100 Participants
n=39 Participants
|
1073 Participants
n=41 Participants
|
2173 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
80 Participants
n=39 Participants
|
100 Participants
n=41 Participants
|
180 Participants
n=35 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 14.33 • n=39 Participants
|
42.9 years
STANDARD_DEVIATION 14.68 • n=41 Participants
|
42.7 years
STANDARD_DEVIATION 14.51 • n=35 Participants
|
|
Sex: Female, Male
Female
|
810 Participants
n=39 Participants
|
843 Participants
n=41 Participants
|
1653 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
399 Participants
n=39 Participants
|
369 Participants
n=41 Participants
|
768 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
156 Participants
n=39 Participants
|
136 Participants
n=41 Participants
|
292 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1052 Participants
n=39 Participants
|
1075 Participants
n=41 Participants
|
2127 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
848 Participants
n=39 Participants
|
849 Participants
n=41 Participants
|
1697 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
219 Participants
n=39 Participants
|
219 Participants
n=41 Participants
|
438 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
9 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
19 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
47 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
99 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
37 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation, step-up in maintenance therapy, or interim analysis DCO, up to one year following treatment initiation.Population: Full analysis set; \>=12 years
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1209 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1212 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)
|
62 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation, a step-up in maintenance therapy or interim analysis DCO, up to one year following treatment initiation.Population: Full analysis set; \>=12 years
The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation occurred. Participants were censored at study completion or withdrawal, or the interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The key secondary outcome measure was analyzed at the interim analysis (22 April 2024). Since the key secondary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1209 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1212 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)
|
64 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=18 years
The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Participants were censored at treatment discontinuation or a step-up in maintenance therapy. An asthma exacerbation was considered severe if it results in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1180 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1173 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years)
|
71 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=18 years
The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the Final DCO (20 September 2024). Participants were censored at study completion or withdrawal. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1180 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1173 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years)
|
73 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=12 years
The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1209 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1212 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years)
|
0.15 events per year
Interval 0.11 to 0.2
|
0.32 events per year
Interval 0.25 to 0.41
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=18 years
The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1180 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1173 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years)
|
0.15 events per year
Interval 0.12 to 0.2
|
0.33 events per year
Interval 0.26 to 0.43
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=12 years
The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1204 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1203 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years)
|
23.2 mg/year
Interval 0.0 to 2840.8
|
61.9 mg/year
Interval 0.0 to 21915.0
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=18 years
The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1175 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1164 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years)
|
23.0 mg/year
Interval 0.0 to 2840.8
|
63.0 mg/year
Interval 0.0 to 21915.0
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=12 years
The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1204 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1203 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years)
|
0.4 days
Standard Deviation 2.17
|
0.9 days
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.Population: Full analysis set; \>=18 years
The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.
Outcome measures
| Measure |
BDA MDI (PT027) 160/180 μg
n=1175 Participants
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1164 Participants
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years)
|
0.4 days
Standard Deviation 2.20
|
0.9 days
Standard Deviation 3.72
|
Adverse Events
BDA MDI (PT027) 160/180 μg
Serious events: 37 serious events
Other events: 227 other events
Deaths: 2 deaths
AS MDI (PT007) 180 µg
Serious events: 37 serious events
Other events: 232 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BDA MDI (PT027) 160/180 μg
n=1209 participants at risk
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1212 participants at risk
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.17%
2/1209 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
COVID-19
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Influenza
|
0.17%
2/1209 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Mastitis
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.25%
3/1212 • Number of events 3 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Post procedural infection
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Pyelonephritis
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Sepsis
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Septic shock
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Psychiatric disorders
Alcoholism
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Psychiatric disorders
Mental status changes
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Psychiatric disorders
Schizoaffective disorder bipolar type
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Psychiatric disorders
Suicidal ideation
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Dementia
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Headache
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Optic neuritis
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Seizure
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Syncope
|
0.17%
2/1209 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Cardiac disorders
Cardiac failure acute
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.08%
1/1209 • Number of events 3 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Cardiac disorders
Tachycardia
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Vascular disorders
Deep vein thrombosis
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Vascular disorders
Hypertension
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
3/1209 • Number of events 3 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.58%
7/1212 • Number of events 7 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.17%
2/1212 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.17%
2/1212 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.08%
1/1209 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.17%
2/1212 • Number of events 2 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
General disorders
Death
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
General disorders
Non-cardiac chest pain
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Investigations
Drug screen positive
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.08%
1/1209 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.00%
0/1212 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Surgical and medical procedures
Oophorectomy
|
0.00%
0/1209 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
0.08%
1/1212 • Number of events 1 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
Other adverse events
| Measure |
BDA MDI (PT027) 160/180 μg
n=1209 participants at risk
Budesonide/albuterol sulfate, BDA MDI, PT027
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol
|
AS MDI (PT007) 180 µg
n=1212 participants at risk
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
65/1209 • Number of events 74 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
6.0%
73/1212 • Number of events 80 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
COVID-19
|
5.1%
62/1209 • Number of events 63 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
5.5%
67/1212 • Number of events 69 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
45/1209 • Number of events 46 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
2.6%
32/1212 • Number of events 34 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Sinusitis
|
3.1%
38/1209 • Number of events 41 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
2.5%
30/1212 • Number of events 36 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Infections and infestations
Bronchitis
|
2.4%
29/1209 • Number of events 30 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
2.6%
32/1212 • Number of events 36 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
30/1209 • Number of events 31 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
2.4%
29/1212 • Number of events 32 • All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data or results obtained from this study must not be published without prior approval from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER