Trial Outcomes & Findings for EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction) (NCT NCT04509674)

NCT ID: NCT04509674

Last Updated: 2025-01-07

Results Overview

The composite of time to first heart failure hospitalization or all-cause mortality is reported as the incidence rate of the first occurrence of hospitalization for heart failure (HHF) or death, whichever is earliest. The incidence rate was calculated as: the number of patients with an event for hospitalization for heart failure or death by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6522 participants
• Primary outcome timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
• Results posted on: 2025-01-07

Participant Flow

Streamlined, randomised, placebo-controlled, double-blind, parallel-group trial in acute myocardial infarction (MI) hospitalised patients with high-risk for subsequent hospitalization for heart failure (HHF) and mortality. Patients were randomised 1:1 to empagliflozin or placebo within 14 days of hospitalisation. Patients were treated and remained in the trial until approximately a total number of 532 patients had primary endpoint events (i.e. event driven).

All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured all inclusion and none of the exclusion criteria were met. Patients were not to be allocated to a treatment group if any of the entry criteria were violated. The randomised set included all randomised patients, whether treated or not. A patient randomised in error after death (i.e. mis-randomization) would be excluded as per statistical analysis plan definition.

Participant milestones

Measure	Placebo Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Overall Study STARTED	3262	3260
Overall Study Treated	3229	3234
Overall Study COMPLETED	2513	2550
Overall Study NOT COMPLETED	749	710

Reasons for withdrawal

Measure	Placebo Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Overall Study Not treated	33	26
Overall Study Protocol Violation	9	10
Overall Study Lost to Follow-up	31	39
Overall Study Patient refusal to continue, not due to adverse event	452	418
Overall Study Adverse event, serious fatal event	11	4
Overall Study Adverse event, non-fatal event	107	118
Overall Study Other reason than listed	106	95

Baseline Characteristics

EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Baseline characteristics by cohort

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Total n=6522 Participants Total of all reporting groups
Age, Continuous	63.7 Years STANDARD_DEVIATION 10.8 • n=5 Participants	63.6 Years STANDARD_DEVIATION 11.0 • n=7 Participants	63.6 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	813 Participants n=5 Participants	812 Participants n=7 Participants	1625 Participants n=5 Participants
Sex: Female, Male Male	2449 Participants n=5 Participants	2448 Participants n=7 Participants	4897 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	331 Participants n=5 Participants	338 Participants n=7 Participants	669 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2859 Participants n=5 Participants	2866 Participants n=7 Participants	5725 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	72 Participants n=5 Participants	56 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized White	2721 Participants n=5 Participants	2730 Participants n=7 Participants	5451 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	48 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized Asian	413 Participants n=5 Participants	421 Participants n=7 Participants	834 Participants n=5 Participants
Race/Ethnicity, Customized Other, including mixed race	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Missing	73 Participants n=5 Participants	56 Participants n=7 Participants	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Population: Randomised set (RS): All randomised patients, whether treated or not.

The composite of time to first heart failure hospitalization or all-cause mortality is reported as the incidence rate of the first occurrence of hospitalization for heart failure (HHF) or death, whichever is earliest.

The incidence rate was calculated as: the number of patients with an event for hospitalization for heart failure or death by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).

Outcome measures

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Composite of Time to First Heart Failure Hospitalisation or All-cause Mortality	6.58 Pt with events/100 pt-years at risk Interval 5.86 to 7.35	5.85 Pt with events/100 pt-years at risk Interval 5.17 to 6.57

SECONDARY outcome

Timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Population: Randomised set (RS): All randomised patients, whether treated or not.

The total number of hospitalisations for heart failure (HHF) or all-cause mortality is reported using the adjusted event rate.

The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Outcome measures

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Key Secondary Endpoint - Total Number of Hospitalisations for Heart Failure (HHF) or All-cause Mortality	8.25 Events/100 patient-years at risk Interval 6.92 to 9.83	7.14 Events/100 patient-years at risk Interval 5.91 to 8.63

SECONDARY outcome

Timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Population: Randomised set (RS): All randomised patients, whether treated or not.

The total number of non-elective cardiovascular (CV) hospitalisations or all-cause mortality is reported using the adjusted event rate.

The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Outcome measures

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Key Secondary Endpoint - Total Number of Non-elective Cardiovascular (CV) Hospitalisations or All-cause Mortality	16.90 Events/100 patient-years at risk Interval 15.1 to 18.92	15.52 Events/100 patient-years at risk Interval 13.82 to 17.43

SECONDARY outcome

Timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Population: Randomised set (RS): All randomised patients, whether treated or not.

The total number of non-elective all-cause hospitalisations or all-cause mortality is reported using the adjusted event rate.

The adjusted event rate is based on a negative binomial model adjusted for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Outcome measures

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Key Secondary Endpoint - Total Number of Non-elective All-cause Hospitalisations or All-cause Mortality	26.28 Events/100 patient-years at risk Interval 23.92 to 28.87	22.96 Events/100 patient-years at risk Interval 20.84 to 25.31

SECONDARY outcome

Timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Population: Randomised set (RS): All randomised patients, whether treated or not.

The total number of hospitalisations for myocardial infarction (MI) or all-cause mortality is reported using the adjusted event rate.

The adjusted event rate is based on a negative binomial model adjusted for factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.

Outcome measures

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Key Secondary Endpoint - Total Number of Hospitalisations for Myocardial Infarction (MI) or All-cause Mortality	6.27 Events/100 patient-years at risk Interval 5.19 to 7.58	6.66 Events/100 patient-years at risk Interval 5.49 to 8.08

SECONDARY outcome

Timeframe: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.

Population: Randomised set (RS): All randomised patients, whether treated or not.

The time to cardiovascular (CV) mortality is reported as the incidence rate of cardiovascular (CV) mortality, including deaths of unknown cause.

The incidence rate was calculated as: the number of patients with a cardiovascular death event by treatment group during time at risk divided by the total time patients were at risk in that treatment group multiplied by 100 (per 100 Pt-years, Pt as abbreviation of patient).

Outcome measures

Measure	Placebo n=3262 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3260 Participants Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Time to Cardiovascular (CV) Mortality	2.76 Pt with events/100 pt-years at risk Interval 2.31 to 3.25	2.78 Pt with events/100 pt-years at risk Interval 2.33 to 3.28

Adverse Events

Placebo

Serious events: 798 serious events

Other events: 0 other events

Deaths: 178 deaths

Empagliflozin 10 mg

Serious events: 765 serious events

Other events: 0 other events

Deaths: 169 deaths

Serious adverse events

Measure	Placebo n=3229 participants at risk Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.	Empagliflozin 10 mg n=3234 participants at risk Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water.
Blood and lymphatic system disorders Anaemia	0.34% 11/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.28% 9/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Haemolysis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Microcytic anaemia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Pancytopenia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Blood and lymphatic system disorders Thrombocytosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Acute coronary syndrome	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.15% 5/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Acute myocardial infarction	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Angina pectoris	0.87% 28/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.93% 30/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Angina unstable	1.7% 54/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	1.6% 52/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Aortic valve stenosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Arrhythmia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Arrhythmia supraventricular	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Arrhythmic storm	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrial fibrillation	0.53% 17/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.56% 18/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrial flutter	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrial tachycardia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrial thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrioventricular block	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Atrioventricular block complete	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Bradyarrhythmia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Bradycardia	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac aneurysm	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac arrest	0.53% 17/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.34% 11/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac failure	7.1% 230/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	4.9% 159/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac perforation	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac tamponade	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac ventricular disorder	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiac ventricular thrombosis	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.34% 11/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardio-respiratory arrest	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiogenic shock	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Cardiovascular disorder	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Chronic coronary syndrome	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Coronary artery disease	0.43% 14/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.43% 14/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Coronary artery dissection	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Coronary artery insufficiency	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Coronary artery occlusion	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Coronary artery stenosis	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Coronary artery thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Dilated cardiomyopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Dressler's syndrome	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Interventricular septum rupture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Intracardiac thrombus	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Microvascular coronary artery disease	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Mitral valve incompetence	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Myocardial infarction	2.9% 94/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	3.4% 110/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Myocardial injury	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Myocardial ischaemia	0.19% 6/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Myocardial rupture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Nodal rhythm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Palpitations	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Papillary muscle rupture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Pericardial effusion	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Pericardial haemorrhage	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Pericarditis	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Postinfarction angina	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Prinzmetal angina	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Sinus arrest	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Sinus node dysfunction	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Stress cardiomyopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Supraventricular tachycardia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Tachycardia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ventricle rupture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ventricular arrhythmia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ventricular extrasystoles	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ventricular fibrillation	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ventricular flutter	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Cardiac disorders Ventricular tachycardia	0.68% 22/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.56% 18/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Congenital, familial and genetic disorders Buried penis syndrome	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Congenital, familial and genetic disorders Corneal dystrophy	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Ear and labyrinth disorders Sudden hearing loss	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Ear and labyrinth disorders Vertigo	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Diabetic retinopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Macular degeneration	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Macular hole	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Optic ischaemic neuropathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Retinal artery embolism	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Retinal detachment	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Retinal infarction	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Vision blurred	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Eye disorders Visual impairment	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal discomfort	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal pain	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal pain upper	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Abdominal wall haematoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Colitis ischaemic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Diarrhoea	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Duodenal polyp	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Dyspepsia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Enteritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastric ulcer	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastritis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.68% 22/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.87% 28/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Ileus	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Ileus paralytic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Inguinal hernia	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Intestinal angina	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Intestinal metaplasia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Intestinal obstruction	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Irritable bowel syndrome	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Large intestine polyp	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Mechanical ileus	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Melaena	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Nausea	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Oesophageal stenosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Oesophagitis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Oronasal fistula	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Pancreatitis acute	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Pancreatitis chronic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Pelvic floor hernia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Rectal haemorrhage	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Rectal polyp	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Volvulus	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Gastrointestinal disorders Vomiting	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Asthenia	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Cardiac death	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Chest discomfort	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Chest pain	0.37% 12/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.28% 9/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Death	0.65% 21/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.65% 21/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Gait disturbance	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Implant site haematoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Non-cardiac chest pain	0.84% 27/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.87% 28/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Physical deconditioning	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Pyrexia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Sudden cardiac death	0.22% 7/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.28% 9/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Sudden death	0.37% 12/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.34% 11/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Systemic inflammatory response syndrome	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Vascular stent stenosis	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
General disorders Vascular stent thrombosis	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Bile duct stone	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Cholangitis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Cholecystitis	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Cholecystitis acute	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Cholelithiasis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Cholestasis	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Haemorrhagic cholecystitis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Hepatic cirrhosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Ischaemic hepatitis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Liver injury	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Immune system disorders Anaphylactic shock	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Immune system disorders Drug hypersensitivity	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Abdominal abscess	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Abscess limb	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Anal abscess	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Appendicitis	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.15% 5/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Arthritis bacterial	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Arthritis infective	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Bacteraemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations COVID-19	0.77% 25/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.62% 20/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations COVID-19 pneumonia	0.31% 10/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.43% 14/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Campylobacter gastroenteritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Cellulitis	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Clostridial infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Clostridium difficile infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Colonic abscess	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Complicated appendicitis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Coronavirus infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Coronavirus pneumonia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Dental fistula	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Device related infection	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Diabetic gangrene	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Diarrhoea infectious	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Diverticulitis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Endocarditis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Endotoxic shock	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Enteritis infectious	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Enterocolitis bacterial	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Epididymitis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Erysipelas	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Escherichia sepsis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Escherichia urinary tract infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Fungal infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Fungal skin infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Gangrene	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Gastroenteritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Gastroenteritis aeromonas	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Gastroenteritis viral	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Herpes zoster	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Infected fistula	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Infection	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Joint abscess	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Localised infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Neutropenic sepsis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Norovirus infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Ophthalmic herpes zoster	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Osteomyelitis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Perineal infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Peritonitis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Pneumonia	0.93% 30/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.96% 31/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Postoperative wound infection	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Pyelonephritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Pyelonephritis acute	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Renal abscess	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Respiratory tract infection	0.25% 8/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.28% 9/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations SARS-CoV-2 viraemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Salmonellosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Sepsis	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Septic shock	0.19% 6/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Staphylococcal bacteraemia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Staphylococcal sepsis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Tooth abscess	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Urinary tract infection	0.22% 7/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.28% 9/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Urosepsis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Vestibular neuronitis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Infections and infestations Viral infection	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Abdominal injury	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Aortic injury	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Craniocerebral injury	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Craniofacial fracture	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Face injury	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Fall	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Femur fracture	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Head injury	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Hip fracture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Joint dislocation	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Neck injury	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Overdose	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Post procedural complication	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.28% 9/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Post procedural stroke	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Postoperative delirium	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Procedural pneumothorax	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Rib fracture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Road traffic accident	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Sternal fracture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Strangulated incisional hernia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Surgical procedure repeated	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Thermal burn	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Injury, poisoning and procedural complications Wrist fracture	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations Blood pressure increased	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations Clostridium test positive	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations Hepatic enzyme increased	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations International normalised ratio increased	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Investigations Stress echocardiogram abnormal	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Cell death	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Decreased appetite	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Dehydration	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.19% 6/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hyponatraemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Ketoacidosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Polydipsia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Back pain	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Mobility decreased	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Oligoarthritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix cancer metastatic	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma recurrent	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucoepidermoid carcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal neoplasm	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer stage III	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue neoplasm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer metastatic	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Aphasia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Ataxia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Carotid artery stenosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Carotid artery thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cerebral haemorrhage	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cerebral hypoperfusion	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cerebral infarction	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cerebral ischaemia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cerebrovascular accident	0.25% 8/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.25% 8/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Cortical laminar necrosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Dementia	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Dementia Alzheimer's type	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Dizziness	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Epilepsy	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Facial paralysis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Haemorrhage intracranial	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Haemorrhagic stroke	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Headache	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Hemiparesis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Intracranial mass	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Ischaemic stroke	0.34% 11/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.22% 7/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Lacunar infarction	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Lumbar radiculopathy	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Metabolic encephalopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Nervous system disorder	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Paraesthesia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Peroneal nerve palsy	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Post-traumatic epilepsy	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Presyncope	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Radiculopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Ruptured cerebral aneurysm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Seizure	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Status epilepticus	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Subarachnoid haemorrhage	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Syncope	0.59% 19/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.49% 16/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Transient ischaemic attack	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Tremor	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Vascular encephalopathy	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Vertebral artery occlusion	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Nervous system disorders Vertebrobasilar stroke	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Confusional state	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Delirium	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Depression	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Mania	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Psychiatric disorders Mental status changes	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Acute kidney injury	1.3% 43/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.83% 27/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Bladder disorder	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Calculus urinary	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Chronic kidney disease	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Cystitis haemorrhagic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Dysuria	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Haematuria	0.31% 10/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.15% 5/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Nephritis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Nephrolithiasis	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Nephropathy toxic	0.28% 9/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Oliguria	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Polyuria	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Renal colic	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Renal failure	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Renal haematoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Renal impairment	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Renal infarct	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Ureterolithiasis	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Renal and urinary disorders Urinary retention	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Penile scarring	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.19% 6/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal fistula	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.12% 4/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.22% 7/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.22% 7/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.15% 5/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Angioedema	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.12% 4/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Skin and subcutaneous tissue disorders Rash	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Social circumstances Physical assault	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Social circumstances Tobacco user	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Surgical and medical procedures Hospitalisation	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Acute aortic syndrome	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Aortic aneurysm	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Aortic stenosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Aortic thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Arterial thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Arteriosclerosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Blood pressure inadequately controlled	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Circulatory collapse	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Deep vein thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Extremity necrosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Femoral artery embolism	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Haematoma	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypertension	0.09% 3/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypertensive crisis	0.15% 5/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.22% 7/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypertensive emergency	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypertensive urgency	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypotension	0.22% 7/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.25% 8/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Hypovolaemic shock	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Iliac artery arteriosclerosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Intermittent claudication	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Jugular vein thrombosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Peripheral arterial occlusive disease	0.06% 2/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Peripheral artery occlusion	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.06% 2/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Peripheral embolism	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Peripheral ischaemia	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.09% 3/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Subclavian artery stenosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Subclavian vein stenosis	0.03% 1/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.00% 0/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Superficial vein thrombosis	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Vascular disorders Vasoconstriction	0.00% 0/3229 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.	0.03% 1/3234 • All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. All-cause mortality- Randomised set: All randomised patients, whether treated or not. Adverse event reporting - Treated set: all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.

Other adverse events

Adverse event data not reported

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER