Trial Outcomes & Findings for A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation (NCT NCT04102098)
NCT ID: NCT04102098
Last Updated: 2026-03-19
Results Overview
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
668 participants
Primary outcome timeframe
Baseline up to approximately 33 months
Results posted on
2026-03-19
Participant Flow
This study was conducted at 134 centers in 26 countries/regions.
A total of 668 participants were randomized to the Atezo+Bev arm or the Active Surveillance (AS) arm (334 participants in each arm). Participants randomized to the Active Surveillance arm were offered the option to cross over to the Atezo+Bev arm after disease recurrence. 81 participants from the Active Surveillance arm crossed over to receive treatment with Atezo+Bev.
Participant milestones
| Measure |
Active Surveillance
Active surveillance of participants.
|
Atezolizumab + Bevacizumab
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
|---|---|---|
|
Main Study Period
STARTED
|
334
|
334
|
|
Main Study Period
COMPLETED
|
0
|
0
|
|
Main Study Period
NOT COMPLETED
|
334
|
334
|
|
Crossover: AS Who Crossed Over
STARTED
|
81
|
0
|
|
Crossover: AS Who Crossed Over
COMPLETED
|
0
|
0
|
|
Crossover: AS Who Crossed Over
NOT COMPLETED
|
81
|
0
|
Reasons for withdrawal
| Measure |
Active Surveillance
Active surveillance of participants.
|
Atezolizumab + Bevacizumab
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
|---|---|---|
|
Main Study Period
Ongoing in study
|
302
|
291
|
|
Main Study Period
Death
|
20
|
27
|
|
Main Study Period
Lost to Follow-up
|
1
|
1
|
|
Main Study Period
Physician Decision
|
0
|
1
|
|
Main Study Period
Withdrawal by Subject
|
11
|
14
|
|
Crossover: AS Who Crossed Over
Withdrawal by Subject
|
1
|
0
|
|
Crossover: AS Who Crossed Over
Death
|
11
|
0
|
|
Crossover: AS Who Crossed Over
Ongoing in study
|
69
|
0
|
Baseline Characteristics
A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Baseline characteristics by cohort
| Measure |
Arm B (Active Surveillance)
n=334 Participants
Active surveillance of participants.
|
Arm A (Atezolizumab Plus Bevacizumab)
n=334 Participants
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
Total
n=668 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 Years
STANDARD_DEVIATION 12.5 • n=110 Participants
|
59.0 Years
STANDARD_DEVIATION 12.1 • n=114 Participants
|
59.0 Years
STANDARD_DEVIATION 12.3 • n=224 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=110 Participants
|
57 Participants
n=114 Participants
|
113 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
278 Participants
n=110 Participants
|
277 Participants
n=114 Participants
|
555 Participants
n=224 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=110 Participants
|
3 Participants
n=114 Participants
|
4 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Asian
|
269 Participants
n=110 Participants
|
276 Participants
n=114 Participants
|
545 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=110 Participants
|
35 Participants
n=114 Participants
|
76 Participants
n=224 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
2 Participants
n=114 Participants
|
2 Participants
n=224 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=110 Participants
|
16 Participants
n=114 Participants
|
37 Participants
n=224 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 33 monthsPopulation: The ITT population is defined as all randomized patients, whether or not the patient has received the assigned study treatment.
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).
Outcome measures
| Measure |
Arm B (Active Surveillance)
n=334 Participants
Active surveillance of participants.
|
Arm A (Atezolizumab Plus Bevacizumab)
n=334 Participants
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
|---|---|---|
|
Recurrence-Free Survival (RFS), as Determined by IRF
|
NA Months
Interval 21.4 to
Insufficient number of participants with event.
|
NA Months
Interval 22.1 to
Insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Baseline up to approximately 91 monthsOS is defined as the time from randomization to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 91 monthsRFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an investigator, or death from any cause (whichever occurs first).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 91 monthsTTR defined as the time from randomization to first documented occurrence of intrahepatic or extrahepatic HCC, as determined by the investigator and by an IRF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 24 months and up to 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to 24 months and up to 36 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 24 and 36 monthsOS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 91 monthsTime to EHS or macrovascular invasion after randomization, defined as the time from randomization to the first appearance of EHS or macrovascular invasion, as determined by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 91 monthsRFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 91 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to any drug administration on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16, and 30 minutes after end of atezolizumab infusion on Day 1 of Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic (PK) analysis population will consist of all patients whom had received any amount of study drug and had at least one measurable serum concentration result post-dose available at the clinical data cutoff for the clinical study report.
Serum concentration of atezolizumab.
Outcome measures
| Measure |
Arm B (Active Surveillance)
n=329 Participants
Active surveillance of participants.
|
Arm A (Atezolizumab Plus Bevacizumab)
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
|---|---|---|
|
Serum Concentration of Atezolizumab
Cycle 1 Day 1
|
NA μg/ mL
Standard Deviation NA
Prior to atezolizumab infusion.
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 1 Day 1, 30 Min After End of Atezo
|
440 μg/ mL
Standard Deviation 132
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 2 Day 1
|
88.7 μg/ mL
Standard Deviation 30.4
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 3 Day 1
|
137 μg/ mL
Standard Deviation 53.0
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 4 Day 1
|
159 μg/ mL
Standard Deviation 58.5
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 8 Day 1
|
196 μg/ mL
Standard Deviation 86.2
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 12 Day 1
|
202 μg/ mL
Standard Deviation 90.1
|
—
|
|
Serum Concentration of Atezolizumab
Cycle 16 Day 1
|
204 μg/ mL
Standard Deviation 89.2
|
—
|
SECONDARY outcome
Timeframe: Prior to any drug administration up to approximately 33 monthPopulation: The immunogenicity analysis population consisted of all participants who received any amount of study drug and had at least one measurable anti-drug antibody (ADA) result post-dose available at the clinical data cutoff for the clinical study report.
Number of participants with anti-drug antibodies to atezolizumab.
Outcome measures
| Measure |
Arm B (Active Surveillance)
n=328 Participants
Active surveillance of participants.
|
Arm A (Atezolizumab Plus Bevacizumab)
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Baseline evaluable participants
|
8 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Post-baseline evaluable participants
|
75 Participants
|
—
|
Adverse Events
Active Surveillance
Serious events: 34 serious events
Other events: 111 other events
Deaths: 20 deaths
Atezolizumab+Bevacizumab
Serious events: 80 serious events
Other events: 296 other events
Deaths: 27 deaths
Crossover: Atezolizumab+Bevacizumab
Serious events: 10 serious events
Other events: 63 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Active Surveillance
n=330 participants at risk
Active surveillance of participants.
|
Atezolizumab+Bevacizumab
n=332 participants at risk
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
Crossover: Atezolizumab+Bevacizumab
n=81 participants at risk
Participants in the Active Surveillance who crossed over to receive Atezo+Bev.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Eye disorders
Cataract
|
0.61%
2/330 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Eye disorders
Retinal tear
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Eye disorders
Uveitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Abdominal wall mass
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.90%
3/332 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.61%
2/330 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.5%
5/332 • Number of events 6 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Hernia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Impaired healing
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Localised oedema
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Pyrexia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
3.7%
3/81 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.91%
3/330 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Cholangitis
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Jaundice
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Immune system disorders
Anaphylactic reaction
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
COVID-19
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
4/332 • Number of events 5 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Liver abscess
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Otitis media
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Pneumonia aspiration
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Blood glucose increased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Hepatic enzyme increased
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Platelet count decreased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.90%
3/332 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Transaminases increased
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage 0
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm benign
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Psychiatric disorders
Anxiety
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Psychiatric disorders
Suicidal ideation
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Psychiatric disorders
Suicide attempt
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Calculus bladder
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.30%
1/330 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.60%
2/332 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.90%
3/332 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.30%
1/332 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Vascular disorders
Hypertension
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.90%
3/332 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/332 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
Other adverse events
| Measure |
Active Surveillance
n=330 participants at risk
Active surveillance of participants.
|
Atezolizumab+Bevacizumab
n=332 participants at risk
Participants received Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
|
Crossover: Atezolizumab+Bevacizumab
n=81 participants at risk
Participants in the Active Surveillance who crossed over to receive Atezo+Bev.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
4/330 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
3.6%
12/332 • Number of events 12 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.2%
5/81 • Number of events 8 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/330 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.3%
21/332 • Number of events 21 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
4.9%
4/81 • Number of events 5 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Endocrine disorders
Hypothyroidism
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
14.2%
47/332 • Number of events 49 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
11.1%
9/81 • Number of events 9 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
10/330 • Number of events 11 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
8.7%
29/332 • Number of events 38 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
4.9%
4/81 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Fatigue
|
1.2%
4/330 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
8.4%
28/332 • Number of events 31 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.2%
5/81 • Number of events 5 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Oedema peripheral
|
0.61%
2/330 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
5.4%
18/332 • Number of events 20 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
General disorders
Pyrexia
|
2.1%
7/330 • Number of events 7 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
9.9%
33/332 • Number of events 41 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
7.4%
6/81 • Number of events 7 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
9/330 • Number of events 11 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
7.5%
25/332 • Number of events 27 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Alanine aminotransferase increased
|
5.5%
18/330 • Number of events 19 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
13.9%
46/332 • Number of events 58 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
14.8%
12/81 • Number of events 16 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Aspartate aminotransferase increased
|
5.5%
18/330 • Number of events 18 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
15.4%
51/332 • Number of events 67 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
16.0%
13/81 • Number of events 16 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Blood bilirubin increased
|
7.0%
23/330 • Number of events 30 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
9.9%
33/332 • Number of events 59 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
8.6%
7/81 • Number of events 8 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.5%
5/330 • Number of events 5 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
5.1%
17/332 • Number of events 26 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
3.7%
3/81 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Lymphocyte count decreased
|
1.8%
6/330 • Number of events 7 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.6%
22/332 • Number of events 37 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
2.5%
2/81 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Neutrophil count decreased
|
2.4%
8/330 • Number of events 12 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
8.7%
29/332 • Number of events 60 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.2%
5/81 • Number of events 5 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Platelet count decreased
|
6.7%
22/330 • Number of events 27 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
19.9%
66/332 • Number of events 101 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
21.0%
17/81 • Number of events 19 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
Weight increased
|
3.3%
11/330 • Number of events 12 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
5.1%
17/332 • Number of events 26 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Investigations
White blood cell count decreased
|
3.0%
10/330 • Number of events 13 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
8.4%
28/332 • Number of events 76 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
3.7%
3/81 • Number of events 4 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.61%
2/330 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.3%
21/332 • Number of events 32 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
0.00%
0/81 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
8/330 • Number of events 9 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
12.0%
40/332 • Number of events 43 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
9.9%
8/81 • Number of events 9 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
9.6%
32/332 • Number of events 39 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Nervous system disorders
Headache
|
1.8%
6/330 • Number of events 6 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
5.7%
19/332 • Number of events 23 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
2.5%
2/81 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Haematuria
|
0.61%
2/330 • Number of events 2 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.3%
21/332 • Number of events 34 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
3.7%
3/81 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
12/330 • Number of events 14 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
46.1%
153/332 • Number of events 227 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
30.9%
25/81 • Number of events 29 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
7/330 • Number of events 7 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.6%
22/332 • Number of events 22 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
1.2%
1/81 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
6.0%
20/332 • Number of events 23 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
7.4%
6/81 • Number of events 6 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.91%
3/330 • Number of events 3 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
12.0%
40/332 • Number of events 45 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
7.4%
6/81 • Number of events 7 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.30%
1/330 • Number of events 1 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
12.0%
40/332 • Number of events 44 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
11.1%
9/81 • Number of events 9 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
|
Vascular disorders
Hypertension
|
3.0%
10/330 • Number of events 11 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
38.0%
126/332 • Number of events 157 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
30.9%
25/81 • Number of events 28 • From the first study drug administration to the data cutoff date: 21 October 2022 (up to approximately 33 months).
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. All-cause mortality reported for the surveillance arm includes participants from the main study period and crossover period. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment. Serious and other adverse events were reported separately for participants who crossed over.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER