Trial Outcomes & Findings for A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease (NCT NCT03036150)

NCT ID: NCT03036150

Last Updated: 2021-07-07

Results Overview

End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4304 participants
• Primary outcome timeframe: Up to 38.2 months
• Results posted on: 2021-07-07

Participant Flow

Participant milestones

Measure	Dapagliflozin Dapagliflozin 10 mg, given once daily per oral use	Placebo Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Overall Study STARTED	2152	2152
Overall Study COMPLETED	2142	2147
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Measure	Dapagliflozin Dapagliflozin 10 mg, given once daily per oral use	Placebo Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Overall Study Withdrawal by Subject	8	3
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Dapagliflozin n=2152 Participants Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2152 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use	Total n=4304 Participants Total of all reporting groups
Age, Continuous	61.8 Years STANDARD_DEVIATION 12.1 • n=5 Participants	61.9 Years STANDARD_DEVIATION 12.1 • n=7 Participants	61.8 Years STANDARD_DEVIATION 12.1 • n=5 Participants
Age, Customized <= 50 years	362 Participants n=5 Participants	370 Participants n=7 Participants	732 Participants n=5 Participants
Age, Customized > 50 years	1790 Participants n=5 Participants	1782 Participants n=7 Participants	3572 Participants n=5 Participants
Age, Customized <= 65 years	1247 Participants n=5 Participants	1239 Participants n=7 Participants	2486 Participants n=5 Participants
Age, Customized > 65 years	905 Participants n=5 Participants	913 Participants n=7 Participants	1818 Participants n=5 Participants
Age, Customized <=65 years	1247 Participants n=5 Participants	1239 Participants n=7 Participants	2486 Participants n=5 Participants
Age, Customized 66-75 years	663 Participants n=5 Participants	667 Participants n=7 Participants	1330 Participants n=5 Participants
Age, Customized > 75 years	242 Participants n=5 Participants	246 Participants n=7 Participants	488 Participants n=5 Participants
Sex: Female, Male Female	709 Participants n=5 Participants	716 Participants n=7 Participants	1425 Participants n=5 Participants
Sex: Female, Male Male	1443 Participants n=5 Participants	1436 Participants n=7 Participants	2879 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	522 Participants n=5 Participants	550 Participants n=7 Participants	1072 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1630 Participants n=5 Participants	1602 Participants n=7 Participants	3232 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	1124 Participants n=5 Participants	1166 Participants n=7 Participants	2290 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	104 Participants n=5 Participants	87 Participants n=7 Participants	191 Participants n=5 Participants
Race/Ethnicity, Customized Asian	749 Participants n=5 Participants	718 Participants n=7 Participants	1467 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	62 Participants n=5 Participants	74 Participants n=7 Participants	136 Participants n=5 Participants
Race/Ethnicity, Customized Other	112 Participants n=5 Participants	106 Participants n=7 Participants	218 Participants n=5 Participants
Most likely etiology of CKD Diabetic Nephropathy	1271 Participants n=5 Participants	1239 Participants n=7 Participants	2510 Participants n=5 Participants
Most likely etiology of CKD Ischaemic/Hypertensive Nephropathy	324 Participants n=5 Participants	363 Participants n=7 Participants	687 Participants n=5 Participants
Most likely etiology of CKD Chronic Glomerulonephritis	343 Participants n=5 Participants	352 Participants n=7 Participants	695 Participants n=5 Participants
Most likely etiology of CKD Other or unknown cause of CKD	214 Participants n=5 Participants	198 Participants n=7 Participants	412 Participants n=5 Participants
eGFR	43.2 mL/min/1.73 m2 STANDARD_DEVIATION 12.3 • n=5 Participants	43.0 mL/min/1.73 m2 STANDARD_DEVIATION 12.4 • n=7 Participants	43.1 mL/min/1.73 m2 STANDARD_DEVIATION 12.4 • n=5 Participants
Urine albumin creatinine ratio	965 mg/g n=5 Participants	934 mg/g n=7 Participants	949 mg/g n=5 Participants
Type 2 Diabetes Mellitus at Baseline Yes	1455 Participants n=5 Participants	1451 Participants n=7 Participants	2906 Participants n=5 Participants
Type 2 Diabetes Mellitus at Baseline No	697 Participants n=5 Participants	701 Participants n=7 Participants	1398 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 38.2 months

Population: For the primary endpoint the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

End Stage Renal Disease (ESRD) is defined as:

• Sustained eGFR <15 mL/min/1.73m2 or,
• Chronic dialysis treatment or,
• Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Outcome measures

Measure	Dapagliflozin n=2152 Participants Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2152 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.	197 Participants	312 Participants

SECONDARY outcome

Timeframe: Up to 38.2 months

Population: For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

End Stage Renal Disease (ESRD) is defined as:

• Sustained eGFR <15 mL/min/1.73m2 or,
• Chronic dialysis treatment or,
• Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Outcome measures

Measure	Dapagliflozin n=2152 Participants Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2152 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.	142 Participants	243 Participants

SECONDARY outcome

Timeframe: Up to 38.2 months

Population: For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Outcome measures

Measure	Dapagliflozin n=2152 Participants Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2152 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.	100 Participants	138 Participants

SECONDARY outcome

Timeframe: Up to 38.2 months

Population: For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Outcome measures

Measure	Dapagliflozin n=2152 Participants Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2152 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Time to Death From Any Cause.	101 Participants	146 Participants

Adverse Events

Dapa 10 mg

Serious events: 633 serious events

Other events: 479 other events

Deaths: 107 deaths

Placebo

Serious events: 729 serious events

Other events: 500 other events

Deaths: 159 deaths

Serious adverse events

Measure	Dapa 10 mg n=2149 participants at risk Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2149 participants at risk Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Thermal burn	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Tibia fracture	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	0.33% 7/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Blood loss anaemia	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Nephrogenic anaemia	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Acute coronary syndrome	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Acute left ventricular failure	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.47% 10/2149 • Number of events 12 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	1.5% 32/2149 • Number of events 35 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.1% 46/2149 • Number of events 56 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.19% 4/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.42% 9/2149 • Number of events 9 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Angina unstable	0.65% 14/2149 • Number of events 17 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.0% 22/2149 • Number of events 26 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Aortic valve disease	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Aortic valve incompetence	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Arteriosclerosis coronary artery	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.79% 17/2149 • Number of events 18 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrial flutter	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrioventricular block	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrioventricular block complete	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrioventricular block second degree	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Bradyarrhythmia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Bradycardia	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Bundle branch block left	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.47% 10/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure	1.8% 39/2149 • Number of events 56 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.7% 59/2149 • Number of events 72 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure acute	0.19% 4/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.33% 7/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	0.60% 13/2149 • Number of events 17 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.0% 22/2149 • Number of events 29 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiogenic shock	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiomyopathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiopulmonary failure	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiorenal syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Chronic left ventricular failure	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Congestive cardiomyopathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.47% 10/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Coronary artery stenosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Defect conduction intraventricular	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Hypertensive heart disease	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ischaemic cardiomyopathy	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Left ventricular dysfunction	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Left ventricular failure	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Mitral valve incompetence	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	0.51% 11/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Prinzmetal angina	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular hypokinesia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Ear and labyrinth disorders Vestibular disorder	0.23% 5/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Goitre	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Hyperadrenocorticism	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Hyperparathyroidism primary	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Pituitary-dependent cushing's syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Toxic nodular goitre	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Cataract	0.37% 8/2149 • Number of events 12 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Cataract subcapsular	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Diabetic retinal oedema	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Diabetic retinopathy	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Diplopia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Glaucoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Ocular hyperaemia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Ocular ischaemic syndrome	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Retinal haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Vitreous disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Vitreous haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal hernia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal hernia obstructive	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal wall haematoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diabetic gastroparesis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diverticular perforation	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer perforation	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Enteritis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Faecaloma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Food poisoning	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastric disorder	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastritis hypertrophic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal angiectasia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Haemoperitoneum	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Mechanical ileus	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric artery thrombosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric vascular insufficiency	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric vein thrombosis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Obstruction gastric	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal stenosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Palatal disorder	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.23% 5/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis chronic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis relapsing	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Peptic ulcer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Varices oesophageal	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Asthenia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Cardiac death	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Catheter site haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Chest pain	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Death	0.70% 15/2149 • Number of events 15 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.3% 27/2149 • Number of events 27 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Fatigue	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Gait disturbance	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Generalised oedema	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Impaired healing	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Inflammation	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Medical device site discomfort	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Medical device site pain	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Multiple organ dysfunction syndrome	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Oedema peripheral	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Pyrexia	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Stent-graft endoleak	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Sudden cardiac death	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Sudden death	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Systemic inflammatory response syndrome	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Bile duct obstruction	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Bile duct stone	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Biliary colic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis acute	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis chronic	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatic cirrhosis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatotoxicity	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Immune system disorders Hypersensitivity	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Immune system disorders Sarcoidosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Immune system disorders Transplant rejection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Abscess	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Abscess limb	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Acquired immunodeficiency syndrome	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Acute hepatitis b	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Anal abscess	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Appendicitis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Appendicitis perforated	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Arthritis bacterial	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Arthritis infective	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bacterial sepsis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Biliary sepsis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bronchitis	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bronchitis bacterial	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bronchitis viral	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bronchopulmonary aspergillosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Covid-19	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Covid-19 pneumonia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Candida infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cellulitis	0.65% 14/2149 • Number of events 17 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.70% 15/2149 • Number of events 20 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cellulitis gangrenous	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cholecystitis infective	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.19% 4/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Clostridium difficile infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Coronavirus infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cystitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cytomegalovirus infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Dengue fever	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Dengue haemorrhagic fever	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Device related infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Device related sepsis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Diabetic foot infection	0.23% 5/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Diabetic gangrene	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Diverticulitis	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Empyema	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Encephalitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Endocarditis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Erysipelas	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Escherichia bacteraemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Escherichia sepsis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Escherichia urinary tract infection	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Fournier's gangrene	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Fungaemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Fungal oesophagitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Furuncle	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gangrene	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gas gangrene	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.47% 10/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.42% 9/2149 • Number of events 9 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastroenteritis salmonella	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastroenteritis viral	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastrointestinal bacterial infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastrointestinal infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infected skin ulcer	0.09% 2/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infectious pleural effusion	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Influenza	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Inguinal hernia gangrenous	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Intestinal sepsis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Large intestine infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Leishmaniasis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Liver abscess	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Localised infection	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Mastoiditis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Mediastinitis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Meningitis bacterial	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Meningoencephalitis herpetic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Necrotising fasciitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Osteomyelitis	0.47% 10/2149 • Number of events 12 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.56% 12/2149 • Number of events 13 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Osteomyelitis chronic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Otitis externa	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Otitis media	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Peritonitis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Peritonsillar abscess	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pilonidal cyst	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Plasmodium falciparum infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia	2.0% 44/2149 • Number of events 50 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	3.3% 70/2149 • Number of events 79 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia bacterial	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia fungal	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia haemophilus	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia influenzal	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia legionella	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Post procedural infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Postoperative wound infection	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pulmonary sepsis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pyelonephritis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pyelonephritis acute	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pyonephrosis	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Rocky mountain spotted fever	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Sepsis	0.60% 13/2149 • Number of events 13 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.84% 18/2149 • Number of events 18 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Septic shock	0.51% 11/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.51% 11/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Skin infection	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Soft tissue infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Splenic abscess	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Staphylococcal bacteraemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Staphylococcal sepsis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Streptococcal bacteraemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Streptococcal endocarditis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Subcutaneous abscess	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Superinfection viral	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Suspected covid-19	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Tonsillitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Tooth abscess	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Tuberculosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Tuberculosis bladder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.93% 20/2149 • Number of events 22 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.70% 15/2149 • Number of events 21 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urinary tract infection bacterial	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urogenital infection bacterial	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urosepsis	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Varicella zoster virus infection	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Vestibular neuronitis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Vulval cellulitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Wound infection	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Accidental overdose	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous graft aneurysm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Chest injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Concussion	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Foot fracture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Foreign body aspiration	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Hand fracture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Humerus fracture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Inflammation of wound	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Injury	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint injury	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Lenticular injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Ligament rupture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb traumatic amputation	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Lower limb fracture	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Multiple fractures	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Multiple injuries	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Muscle strain	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Patella fracture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Pelvic fracture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural bile leak	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural complication	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural fever	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Radiation proctitis	0.05% 1/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Radius fracture	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Scapula fracture	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin laceration	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal fracture	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Upper limb fracture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular access malfunction	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound evisceration	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood creatinine increased	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood glucose increased	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood parathyroid hormone increased	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood pressure increased	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Fibrin d dimer increased	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Glomerular filtration rate decreased	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Oxygen saturation decreased	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Acidosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Cachexia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.33% 7/2149 • Number of events 9 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.42% 9/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Electrolyte imbalance	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid overload	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.28% 6/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.79% 17/2149 • Number of events 19 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.56% 12/2149 • Number of events 12 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.42% 9/2149 • Number of events 9 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.84% 18/2149 • Number of events 19 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophagia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypovolaemia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Lactic acidosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Metabolic disorder	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Milk-alkali syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Shock hypoglycaemic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteolysis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign biliary neoplasm	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone giant cell tumour malignant	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Craniopharyngioma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage i	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epithelioid mesothelioma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer metastatic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoplasmacytoid lymphoma/immunocytoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bladder	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral t-cell lymphoma unspecified recurrent	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.47% 10/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage ii	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage iv	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal hamartoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue neoplasm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular germ cell cancer metastatic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vocal cord neoplasm	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Altered state of consciousness	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain hypoxia	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain injury	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain oedema	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain stem haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain stem infarction	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain stem stroke	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Carotid artery aneurysm	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Carotid artery occlusion	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Carotid artery stenosis	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Carpal tunnel syndrome	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebellar stroke	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral ischaemia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral vasoconstriction	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.47% 10/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebrovascular disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Dementia	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Dysarthria	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Embolic stroke	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Epilepsy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Facial nerve disorder	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Facial paralysis	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Guillain-barre syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Haemorrhagic stroke	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Hemiparesis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Intracranial aneurysm	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Intraventricular haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Ischaemic cerebral infarction	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Ischaemic stroke	1.0% 22/2149 • Number of events 23 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.3% 28/2149 • Number of events 29 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Lacunar stroke	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Lumbar radiculopathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Metabolic encephalopathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Motor neurone disease	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Multiple sclerosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Partial seizures	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Presyncope	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Putamen haemorrhage	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Radiculopathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Seizure	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Syncope	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Tension headache	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Thalamic infarction	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Toxic encephalopathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.51% 11/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.42% 9/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Vascular encephalopathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Anembryonic gestation	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Premature separation of placenta	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device dislocation	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device malfunction	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device power source issue	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Completed suicide	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Delirium	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Depression	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Hallucination, visual	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Post stroke depression	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Sleep disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Suicidal ideation	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Suicide attempt	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	1.8% 39/2149 • Number of events 43 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.4% 52/2149 • Number of events 64 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Bladder tamponade	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.93% 20/2149 • Number of events 24 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.4% 31/2149 • Number of events 34 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Diabetic nephropathy	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders End stage renal disease	1.2% 26/2149 • Number of events 27 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.7% 36/2149 • Number of events 39 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Glomerulonephritis chronic	0.09% 2/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 9 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Glomerulonephritis rapidly progressive	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Iga nephropathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Intercapillary glomerulosclerosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephropathy	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephropathy toxic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephrosclerosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephrotic syndrome	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Obstructive nephropathy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Prerenal failure	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal amyloidosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal colic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.47% 10/2149 • Number of events 11 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	0.65% 14/2149 • Number of events 15 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.70% 15/2149 • Number of events 15 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal mass	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Tubulointerstitial nephritis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urate nephropathy	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Ureteric stenosis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Ureterolithiasis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urethral dilatation	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urethral stenosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urinary incontinence	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urinary retention	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urinary tract obstruction	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Vesical fistula	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Balanoposthitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Endometrial disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Prostatomegaly	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Seminal vesicular cyst	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Uterine polyp	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.56% 12/2149 • Number of events 14 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.51% 11/2149 • Number of events 12 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.33% 7/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.47% 10/2149 • Number of events 13 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.19% 4/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Diabetic foot	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.33% 7/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic aneurysm	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic aneurysm rupture	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic dissection	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic stenosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Arterial occlusive disease	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Arteriosclerosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Diabetic vascular disorder	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Dry gangrene	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Extremity necrosis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Femoral artery embolism	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Granulomatosis with polyangiitis	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Haematoma	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertension	0.42% 9/2149 • Number of events 13 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.47% 10/2149 • Number of events 10 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertensive crisis	0.28% 6/2149 • Number of events 6 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.23% 5/2149 • Number of events 5 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertensive emergency	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.28% 6/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertensive urgency	0.09% 2/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypotension	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypovolaemic shock	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Iliac artery embolism	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Iliac artery stenosis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral arterial occlusive disease	0.28% 6/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.33% 7/2149 • Number of events 7 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral artery occlusion	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral artery stenosis	0.14% 3/2149 • Number of events 3 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral artery thrombosis	0.05% 1/2149 • Number of events 2 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral ischaemia	0.19% 4/2149 • Number of events 4 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.37% 8/2149 • Number of events 8 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral vascular disorder	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Shock haemorrhagic	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Thrombophlebitis	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Venous thrombosis limb	0.05% 1/2149 • Number of events 1 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2149 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.

Other adverse events

Measure	Dapa 10 mg n=2149 participants at risk Dapagliflozin 10 mg, given once daily per oral use	Placebo n=2149 participants at risk Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
Gastrointestinal disorders Diarrhoea	2.1% 45/2149 • Number of events 56 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	1.9% 41/2149 • Number of events 46 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
General disorders Oedema peripheral	2.5% 54/2149 • Number of events 56 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.9% 63/2149 • Number of events 75 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	4.3% 92/2149 • Number of events 136 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	3.8% 81/2149 • Number of events 118 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urinary tract infection	3.6% 78/2149 • Number of events 102 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	3.7% 79/2149 • Number of events 96 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Investigations Glomerular filtration rate decreased	1.8% 39/2149 • Number of events 45 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.8% 61/2149 • Number of events 67 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	2.5% 53/2149 • Number of events 67 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.3% 49/2149 • Number of events 54 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	3.4% 74/2149 • Number of events 119 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	3.3% 70/2149 • Number of events 96 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	2.0% 44/2149 • Number of events 46 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.3% 50/2149 • Number of events 52 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	2.3% 49/2149 • Number of events 54 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.0% 44/2149 • Number of events 50 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	2.4% 51/2149 • Number of events 55 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	3.0% 64/2149 • Number of events 72 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertension	2.9% 62/2149 • Number of events 63 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.	2.8% 60/2149 • Number of events 66 • Up to 39.2 months For All Cause Mortality, the Full Analysis Set was used. This included all patients who were randomized to study drug. For analysis of Serious Adverse Events, Safety analysis set was used. Safety analysis set consisted of all randomized patients who received at least one dose of study drug.

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: +1-877-240-9479

Email: Information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place