Trial Outcomes & Findings for Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC (NCT NCT04023227)
NCT ID: NCT04023227
Last Updated: 2026-05-11
Results Overview
The primary efficacy endpoint was analyzed using the win ratio approach comparing every participant in the sacubitril/valsartan arm to every participant in the enalapril arm to determine a winner. A winner in the pair-wise comparison had a delayed time to the occurrence of CV death; if time to the occurrence of CV death was censored, a winner had a delayed time to the occurrence of first HF hospitalization event; if the times to both CV events were censored, a winner had a more favorable (less increase or more decrease) change in NT-proBNP between Baseline and Week 12. The estimated win ratio was defined as the total number of winners in the sacubitril/valsartan arm divided by the total number of winners in the enalapril arm. A win ratio \>1 represents a favorable outcome for the study drug being assessed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
922 participants
Primary outcome timeframe
Total follow-up time up to approximately 36 months
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Sacubitril/Valsartan
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
Enalapril
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
462
|
460
|
|
Overall Study
COMPLETED
|
333
|
318
|
|
Overall Study
NOT COMPLETED
|
129
|
142
|
Reasons for withdrawal
| Measure |
Sacubitril/Valsartan
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
Enalapril
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
|---|---|---|
|
Overall Study
Withdrawal of Participant Consent
|
2
|
8
|
|
Overall Study
Death
|
127
|
134
|
Baseline Characteristics
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC
Baseline characteristics by cohort
| Measure |
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Total
n=922 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 10.6 • n=44 Participants
|
64.2 years
STANDARD_DEVIATION 11.0 • n=10 Participants
|
64.2 years
STANDARD_DEVIATION 10.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=44 Participants
|
201 Participants
n=10 Participants
|
387 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
276 Participants
n=44 Participants
|
259 Participants
n=10 Participants
|
535 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
246 Participants
n=44 Participants
|
256 Participants
n=10 Participants
|
502 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black
|
70 Participants
n=44 Participants
|
70 Participants
n=10 Participants
|
140 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Indigenous
|
24 Participants
n=44 Participants
|
18 Participants
n=10 Participants
|
42 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Mixed Ethnicity
|
122 Participants
n=44 Participants
|
116 Participants
n=10 Participants
|
238 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Total follow-up time up to approximately 36 monthsPopulation: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
The primary efficacy endpoint was analyzed using the win ratio approach comparing every participant in the sacubitril/valsartan arm to every participant in the enalapril arm to determine a winner. A winner in the pair-wise comparison had a delayed time to the occurrence of CV death; if time to the occurrence of CV death was censored, a winner had a delayed time to the occurrence of first HF hospitalization event; if the times to both CV events were censored, a winner had a more favorable (less increase or more decrease) change in NT-proBNP between Baseline and Week 12. The estimated win ratio was defined as the total number of winners in the sacubitril/valsartan arm divided by the total number of winners in the enalapril arm. A win ratio \>1 represents a favorable outcome for the study drug being assessed.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Hierarchical Composite Endpoint Composed of Time to Cardiovascular (CV) Death, Time to First Heart Failure (HF) Hospitalization, and Relative Change in NT-proBNP From Baseline to Week 12
|
67097 wins
|
103086 wins
|
PRIMARY outcome
Timeframe: Total follow up time up to approximately 36 monthsPopulation: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Percentage of Participants Who Died From Cardiovascular Causes
|
25.4 percentage of participants
|
23.8 percentage of participants
|
PRIMARY outcome
Timeframe: Total follow up time up to approximately 36 monthsPopulation: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Percentage of Participants With First Hospitalization for Worsening Heart Failure
|
24.1 percentage of participants
|
22.1 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization. Number analyzed is the number of participants with data available at the specified time point.
Geometric mean factor change was derived from a linear regression model of log(NT-proBNP), adjusted for country and baseline value.
Outcome measures
| Measure |
Enalapril
n=403 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=419 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Change From Baseline to Week 12 in NT-proBNP Levels
|
0.91 picograms per milliliter
Interval 0.82 to 1.01
|
0.62 picograms per milliliter
Interval 0.56 to 0.69
|
SECONDARY outcome
Timeframe: From the date of randomization to the first occurrence (total follow up time up to approximately 36 months)Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Percentage of Participants With First Hospitalization Due to Heart Failure or Death From Cardiovascular Causes
|
36.7 percentage of participants
|
33.5 percentage of participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of death from any cause assessed up to the end of the study, up to approximately 36 monthsPopulation: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Percentage of Participants Who Died From Any Cause
|
29.1 percentage of participants
|
27.9 percentage of participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of the sudden death or resuscitated sudden cardiac arrest assessed up to the end of the study, up to approximately 36 monthsPopulation: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Number of Participants Who Had Sudden Death or Resuscitated Sudden Cardiac Arrest
|
39 participants
|
46 participants
|
SECONDARY outcome
Timeframe: From the date of randomization up to end of study. Total follow up time up to approximately 36 months.Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Number of Participants Who Had Visits to an Emergency Room Due to Heart Failure (HF) Where Intravenous Therapy Was Required
|
21 participants
|
23 participants
|
SECONDARY outcome
Timeframe: From the date of randomization up to end of study. Total follow up time up to approximately 36 months.Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
The duration of hospital-free survival within 1 year from randomization was summarized.
Outcome measures
| Measure |
Enalapril
n=455 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=461 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Number of Days Alive and Out of the Hospital
|
338 days
Standard Deviation 71
|
339 days
Standard Deviation 72
|
SECONDARY outcome
Timeframe: From the date of randomization up to end of study. Total follow up time up to approximately 36 months.Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Number of Hospitalizations Due to Heart Failure (HF) or Death Due to Cardiovascular (CV) Causes (Recurrent Events)
|
316 hospitalizations
|
289 hospitalizations
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization up to end of study. Total follow up time up to approximately 36 months.Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization.
The number of ventricular fibrillation or sustained ventricular tachycardia needing specific pharmacological, electrical or other treatment was determined.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Number of Ventricular Fibrillation or Sustained Ventricular Tachycardia
|
32 events
|
42 events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization up to end of study. Total follow up time up to approximately 36 months.Population: The full analysis set comprised all participants to whom study treatment was assigned at randomization. This measure was assessed in a subset of participants who had an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D) at randomization.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
Number of Anti-tachycardia Pacing or Shock Therapies
|
13 events
|
17 events
|
POST_HOC outcome
Timeframe: On-treatment deaths: Up to approximately 55 months. Post-treatment survival follow-up deaths: Up to an additional 8 months.Population: The analysis included patients who received at least one dose of study drug.
On-treatment deaths: from first dose of study treatment to 30 days following the last dose of study treatment at the end of treatment phase. Survival follow-up deaths: from Day 31 after last dose of study treatment up to study completion.
Outcome measures
| Measure |
Enalapril
n=460 Participants
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
Sacubitril/Valsartan
n=462 Participants
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
|---|---|---|
|
All Collected Deaths
On-treatment deaths
|
134 Participants
|
127 Participants
|
|
All Collected Deaths
Post-treatment survival follow-up deaths
|
0 Participants
|
2 Participants
|
|
All Collected Deaths
All deaths
|
134 Participants
|
129 Participants
|
Adverse Events
Sacubitril/@Valsartan
Serious events: 169 serious events
Other events: 102 other events
Deaths: 129 deaths
Enalapril
Serious events: 183 serious events
Other events: 145 other events
Deaths: 134 deaths
All Participants (Sacubitril/Valsartan and Enalapril)
Serious events: 352 serious events
Other events: 247 other events
Deaths: 263 deaths
Serious adverse events
| Measure |
Sacubitril/@Valsartan
n=462 participants at risk
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
Enalapril
n=460 participants at risk
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
All Participants (Sacubitril/Valsartan and Enalapril)
n=922 participants at risk
Participants received 3 to 6 weeks of titrated dosing with either sacubitril/valsartan (target dose: 200 mg) or enalapril (target dose: 10 mg) twice daily.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Abnormal clotting factor
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.54%
5/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
5/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.76%
7/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Angina pectoris
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Angina unstable
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Arrhythmia
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.87%
4/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.76%
7/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Arrhythmic storm
|
1.5%
7/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.1%
5/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.3%
12/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
8/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.3%
6/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.5%
14/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Atrioventricular block
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
4/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.87%
4/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.54%
5/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Bradycardia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac failure
|
3.0%
14/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
5.0%
23/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
4.0%
37/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac failure acute
|
1.7%
8/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.4%
11/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.1%
19/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.3%
6/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.87%
8/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac valve disease
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.54%
5/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiogenic shock
|
1.5%
7/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.0%
9/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.7%
16/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Chronic myocarditis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.54%
5/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.6%
12/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.8%
13/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.7%
25/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Ventricular asystole
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.0%
14/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.4%
11/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.7%
25/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
4/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Megacolon
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal perforation
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Accidental death
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Asthenia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Brain death
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Chest pain
|
0.87%
4/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.76%
7/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Malaise
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Oedema peripheral
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Sudden death
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
General disorders
Vessel puncture site phlebitis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Liver disorder
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Hepatobiliary disorders
Pseudocholelithiasis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Immune system disorders
Multisystem inflammatory syndrome
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Immune system disorders
Transplant rejection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Acute endocarditis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Appendicitis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Atypical pneumonia
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Breakthrough dengue fever
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Bullous erysipelas
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
COVID-19
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.1%
5/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.87%
8/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Community acquired infection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Complicated appendicitis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Cystitis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Cytomegalovirus gastrointestinal infection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Enterococcal sepsis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.54%
5/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Gastroenteritis viral
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Neurocryptococcosis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pneumonia
|
1.7%
8/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.2%
10/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.0%
18/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
1.7%
8/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.6%
12/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.2%
20/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Postoperative wound infection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pulmonary sepsis
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Pyelonephritis acute
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Sepsis
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.87%
4/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
6/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Septic encephalopathy
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Septic shock
|
2.6%
12/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.5%
7/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.1%
19/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.7%
8/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.2%
11/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Vessel puncture site cellulitis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Infections and infestations
Viral infection
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Atypical femur fracture
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Blood calcium decreased
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Blood potassium decreased
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Blood potassium increased
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Blood sodium decreased
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Blood sodium increased
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Breath sounds abnormal
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Cardiac output decreased
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Coagulation time prolonged
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Heart rate decreased
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
Platelet count decreased
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Investigations
SARS-CoV-2 RNA increased
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.87%
4/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
6/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemic syndrome
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline ovarian tumour
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma stage 0
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage 0
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
6/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Embolic stroke
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
3.0%
14/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
3.0%
14/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
3.0%
28/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.87%
4/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
4/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Seizure
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Syncope
|
1.9%
9/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.7%
8/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.8%
17/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.54%
5/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Product Issues
Device inappropriate shock delivery
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Product Issues
Device malfunction
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
4/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Product Issues
Device pacing issue
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Product Issues
Device power source issue
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
4/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Product Issues
Internal device exposed
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Product Issues
Lead dislodgement
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Psychiatric disorders
Claustrophobia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Psychiatric disorders
Delirium
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Psychiatric disorders
Near death experience
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
15/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
3.5%
16/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
3.4%
31/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
6/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Dysuria
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Renal disorder
|
1.3%
6/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.7%
8/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.5%
14/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.43%
2/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Renal impairment
|
1.5%
7/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.87%
4/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
1.2%
11/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Renal and urinary disorders
Renal injury
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.65%
3/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
6/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.65%
3/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Gastrointestinal surgery
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.43%
2/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.33%
3/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Medical device repositioning
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Arterial occlusive disease
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Circulatory collapse
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Hypotension
|
2.4%
11/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
3.3%
15/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
2.8%
26/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Hypovolaemic shock
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
2/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.22%
1/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Shock
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Shock haemorrhagic
|
0.22%
1/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.00%
0/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
0.11%
1/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
Other adverse events
| Measure |
Sacubitril/@Valsartan
n=462 participants at risk
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
|
Enalapril
n=460 participants at risk
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
|
All Participants (Sacubitril/Valsartan and Enalapril)
n=922 participants at risk
Participants received 3 to 6 weeks of titrated dosing with either sacubitril/valsartan (target dose: 200 mg) or enalapril (target dose: 10 mg) twice daily.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
8.7%
40/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
11.1%
51/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
9.9%
91/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Cardiac disorders
Cardiac failure acute
|
3.5%
16/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
6.7%
31/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
5.1%
47/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
14/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
11.7%
54/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
7.4%
68/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
|
Vascular disorders
Hypotension
|
9.5%
44/462 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
9.3%
43/460 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
9.4%
87/922 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 55 months. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, for an additional 8 months. These were not considered AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER