Trial Outcomes & Findings for Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (NCT NCT03036124)

NCT ID: NCT03036124

Last Updated: 2020-09-01

Results Overview

Primary efficacy

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4744 participants
• Primary outcome timeframe: Up to 27.8 months.
• Results posted on: 2020-09-01

Participant Flow

Participant milestones

Measure	Dapa 10mg 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	2373	2371
Overall Study COMPLETED	2368	2365
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Dapa 10mg 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 Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

Baseline characteristics by cohort

Measure	Dapa 10mg n=2373 Participants Dapagliflozin 10 mg, given once daily per oral use.	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.	Total n=4744 Participants Total of all reporting groups
Age, Continuous	66.2 Years STANDARD_DEVIATION 11.0 • n=5 Participants	66.5 Years STANDARD_DEVIATION 10.8 • n=7 Participants	66.3 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Age, Customized <=50	208 Participants n=5 Participants	188 Participants n=7 Participants	396 Participants n=5 Participants
Age, Customized >50	2165 Participants n=5 Participants	2183 Participants n=7 Participants	4348 Participants n=5 Participants
Age, Customized <=65	1032 Participants n=5 Participants	998 Participants n=7 Participants	2030 Participants n=5 Participants
Age, Customized >65	1341 Participants n=5 Participants	1373 Participants n=7 Participants	2714 Participants n=5 Participants
Age, Customized 66 - 75	825 Participants n=5 Participants	886 Participants n=7 Participants	1711 Participants n=5 Participants
Age, Customized >75	516 Participants n=5 Participants	487 Participants n=7 Participants	1003 Participants n=5 Participants
Sex: Female, Male Female	564 Participants n=5 Participants	545 Participants n=7 Participants	1109 Participants n=5 Participants
Sex: Female, Male Male	1809 Participants n=5 Participants	1826 Participants n=7 Participants	3635 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	381 Participants n=5 Participants	387 Participants n=7 Participants	768 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1992 Participants n=5 Participants	1984 Participants n=7 Participants	3976 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	1662 Participants n=5 Participants	1671 Participants n=7 Participants	3333 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	122 Participants n=5 Participants	104 Participants n=7 Participants	226 Participants n=5 Participants
Race/Ethnicity, Customized Asian	552 Participants n=5 Participants	564 Participants n=7 Participants	1116 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Main etiology of HF Ischaemic	1316 Participants n=5 Participants	1358 Participants n=7 Participants	2674 Participants n=5 Participants
Main etiology of HF Non-Ischaemic	857 Participants n=5 Participants	830 Participants n=7 Participants	1687 Participants n=5 Participants
Main etiology of HF Unknown	200 Participants n=5 Participants	183 Participants n=7 Participants	383 Participants n=5 Participants
Prior HF hospitalization Yes	1124 Participants n=5 Participants	1127 Participants n=7 Participants	2251 Participants n=5 Participants
NYHA class at enrollment II	1606 Participants n=5 Participants	1597 Participants n=7 Participants	3203 Participants n=5 Participants
NYHA class at enrollment III	747 Participants n=5 Participants	751 Participants n=7 Participants	1498 Participants n=5 Participants
NYHA class at enrollment IV	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Type 2 diabetes at baseline Yes	1075 Participants n=5 Participants	1064 Participants n=7 Participants	2139 Participants n=5 Participants
Type 2 diabetes at baseline No	1298 Participants n=5 Participants	1307 Participants n=7 Participants	2605 Participants n=5 Participants
LVEF	31.2 Percentage of blood leaving the heart STANDARD_DEVIATION 6.7 • n=5 Participants	30.9 Percentage of blood leaving the heart STANDARD_DEVIATION 6.9 • n=7 Participants	31.1 Percentage of blood leaving the heart STANDARD_DEVIATION 6.8 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 27.8 months.

Primary efficacy

Outcome measures

Measure	Dapa 10 mg n=2373 Participants Dapagliflozin 10 mg tablets administered orally once daily	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.	386 Participants	502 Participants

SECONDARY outcome

Timeframe: Up to 27.8 months.

Secondary

Outcome measures

Measure	Dapa 10 mg n=2373 Participants Dapagliflozin 10 mg tablets administered orally once daily	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	382 Participants	495 Participants

SECONDARY outcome

Timeframe: Up to 27.8 months.

Secondary

Outcome measures

Measure	Dapa 10 mg n=2373 Participants Dapagliflozin 10 mg tablets administered orally once daily	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.	567 events	742 events

SECONDARY outcome

Timeframe: Baseline and 8 months or death before 8 months

KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Outcome measures

Measure	Dapa 10 mg n=2373 Participants Dapagliflozin 10 mg tablets administered orally once daily	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Change From Baseline in the KCCQ Total Symptom Score	6.1 Scores on a scale Standard Deviation 18.6	3.3 Scores on a scale Standard Deviation 19.2

SECONDARY outcome

Timeframe: Up to 27.8 months.

Secondary

Outcome measures

Measure	Dapa 10 mg n=2373 Participants Dapagliflozin 10 mg tablets administered orally once daily	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	28 Participants	39 Participants

SECONDARY outcome

Timeframe: Up to 27.8 months.

Secondary

Outcome measures

Measure	Dapa 10 mg n=2373 Participants Dapagliflozin 10 mg tablets administered orally once daily	Placebo n=2371 Participants Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Subjects Included in the Endpoint of All-cause Mortality.	276 Participants	329 Participants

Adverse Events

Dapa 10mg

Serious events: 895 serious events

Other events: 299 other events

Deaths: 286 deaths

Placebo

Serious events: 994 serious events

Other events: 325 other events

Deaths: 333 deaths

Serious adverse events

Measure	Dapa 10mg n=2368 participants at risk Dapagliflozin 10 mg, given once daily per oral use.	Placebo n=2368 participants at risk Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Blood and lymphatic system disorders Anaemia	0.13% 3/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.46% 11/2368 • Number of events 13 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Blood and lymphatic system disorders Splenic infarction	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Acute coronary syndrome	0.21% 5/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Acute left ventricular failure	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	1.6% 37/2368 • Number of events 37 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.6% 38/2368 • Number of events 40 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.51% 12/2368 • Number of events 12 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.51% 12/2368 • Number of events 12 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Angina unstable	0.89% 21/2368 • Number of events 24 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.3% 30/2368 • Number of events 31 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Aortic valve incompetence	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Aortic valve stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Arrhythmia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	1.1% 26/2368 • Number of events 27 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.6% 39/2368 • Number of events 43 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrial flutter	0.34% 8/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrial tachycardia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrial thrombosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrioventricular block complete	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Atrioventricular block second degree	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Bradyarrhythmia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Bradycardia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Bundle branch block left	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac aneurysm	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.38% 9/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.42% 10/2368 • Number of events 10 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac disorder	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure	11.1% 262/2368 • Number of events 380 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	14.8% 351/2368 • Number of events 523 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure acute	1.8% 42/2368 • Number of events 58 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	2.5% 59/2368 • Number of events 75 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	1.1% 27/2368 • Number of events 32 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.4% 33/2368 • Number of events 46 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	2.7% 65/2368 • Number of events 102 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	3.0% 70/2368 • Number of events 106 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac tamponade	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac valve disease	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiogenic shock	0.38% 9/2368 • Number of events 10 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.63% 15/2368 • Number of events 16 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiomyopathy	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiopulmonary failure	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiorenal syndrome	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiovascular insufficiency	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Chronic left ventricular failure	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Congestive cardiomyopathy	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.38% 9/2368 • Number of events 10 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Coronary artery insufficiency	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Coronary artery stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Extrasystoles	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Frederick's syndrome	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ischaemic cardiomyopathy	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Left ventricular dysfunction	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Left ventricular failure	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Low cardiac output syndrome	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Mitral valve incompetence	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Myocardial fibrosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	0.68% 16/2368 • Number of events 16 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.72% 17/2368 • Number of events 17 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Palpitations	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Prosthetic cardiac valve thrombosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Pulseless electrical activity	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Right ventricular failure	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Sinus node dysfunction	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Tachyarrhythmia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Torsade de pointes	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Tricuspid valve incompetence	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular arrhythmia	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular extrasystoles	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular fibrillation	0.46% 11/2368 • Number of events 11 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.25% 6/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular tachyarrhythmia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	1.4% 34/2368 • Number of events 41 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	2.3% 54/2368 • Number of events 65 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo positional	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Ear and labyrinth disorders Vestibular disorder	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Hyperthyroidism	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Angle closure glaucoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Cataract	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Diabetic retinopathy	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Glaucoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Optic ischaemic neuropathy	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Retinal artery occlusion	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Strabismus	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Vision blurred	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Eye disorders Vitreous haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal adhesions	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Ascites	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Chronic gastritis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer perforation	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Duodenitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Enteritis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastric haemorrhage	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastritis erosive	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastritis haemorrhagic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal angiectasia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.17% 4/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Haematemesis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Haematochezia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Ileus paralytic	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.38% 9/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Intestinal ischaemia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Intestinal perforation	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Megacolon	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Melaena	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal ulcer	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatic disorder	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatic mass	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis chronic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Rectal polyp	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Umbilical hernia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Asthenia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Cardiac death	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Chest pain	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Complication associated with device	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Death	2.0% 48/2368 • Number of events 48 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	2.0% 48/2368 • Number of events 48 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders General physical health deterioration	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Implant site haemorrhage	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Malaise	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Medical device site inflammation	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Multiple organ dysfunction syndrome	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Necrosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.68% 16/2368 • Number of events 19 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Sudden cardiac death	0.76% 18/2368 • Number of events 18 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.1% 27/2368 • Number of events 27 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Sudden death	0.80% 19/2368 • Number of events 19 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.42% 10/2368 • Number of events 10 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Ulcer haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Vascular stent occlusion	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Vascular stent stenosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
General disorders Vascular stent thrombosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Bile duct stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Bile duct stone	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Biliary dilatation	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis acute	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis chronic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Cryptogenic cirrhosis	0.04% 1/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Gallbladder enlargement	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatic cirrhosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis acute	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Ischaemic hepatitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Hepatobiliary disorders Jaundice cholestatic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Immune system disorders Heart transplant rejection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Abdominal abscess	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Abdominal wall abscess	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Abscess	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Abscess limb	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Acute sinusitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Anal abscess	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Appendicitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Biliary sepsis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bronchitis	0.51% 12/2368 • Number of events 13 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Bursitis infective	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cardiac infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cellulitis	0.38% 9/2368 • Number of events 11 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.42% 10/2368 • Number of events 12 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cellulitis gangrenous	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cervicitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Clostridial infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Cystitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Dengue fever	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Device related infection	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Diabetic foot infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Diabetic gangrene	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Disseminated tuberculosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Diverticulitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Endocarditis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Endocarditis bacterial	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Endotoxic shock	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Enteritis infectious	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Enterococcal bacteraemia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Epididymitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Erysipelas	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Fournier's gangrene	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Furuncle	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gangrene	0.08% 2/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.25% 6/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastrointestinal infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Gastrointestinal viral infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Hiv infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Herpes zoster oticus	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Implant site infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infected dermal cyst	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infected skin ulcer	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infection	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Infectious pleural effusion	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Influenza	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Intestinal sepsis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Liver abscess	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Localised infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Lung infection	0.17% 4/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Lyme disease	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Mediastinal abscess	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Medical device site infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Meningitis tuberculous	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Metapneumovirus infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Oral candidiasis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Oropharyngeal candidiasis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Osteomyelitis	0.30% 7/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Otitis media	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Otitis media acute	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Perichondritis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Periodontitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Peritonitis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia	3.2% 76/2368 • Number of events 83 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	3.5% 82/2368 • Number of events 87 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pneumonia bacterial	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Postoperative abscess	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Postoperative wound infection	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pulmonary sepsis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pulmonary tuberculosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pyelocystitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pyelonephritis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Pyelonephritis acute	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Rectal abscess	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Renal abscess	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Renal cyst infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Respiratory syncytial virus infection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Rickettsiosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Sepsis	0.55% 13/2368 • Number of events 13 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.59% 14/2368 • Number of events 14 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Septic shock	0.34% 8/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Skin infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Staphylococcal infection	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Subdiaphragmatic abscess	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Systemic candida	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Tracheobronchitis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Tuberculosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.46% 11/2368 • Number of events 13 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.72% 17/2368 • Number of events 17 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Urosepsis	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Wound infection	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Acetabulum fracture	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Alcohol poisoning	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Cardiac valve rupture	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Compression fracture	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Poisoning	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Postoperative wound complication	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin injury	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Splenic injury	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic haematoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood creatinine increased	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood glucose increased	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Blood pressure increased	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Ejection fraction decreased	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Glomerular filtration rate decreased	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations International normalised ratio increased	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Pulmonary arterial pressure increased	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Transaminases increased	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Investigations Troponin increased	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.42% 10/2368 • Number of events 10 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.21% 5/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.08% 2/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid overload	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid retention	0.04% 1/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Hypovolaemia	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Ketoacidosis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 degeneration	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.21% 5/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pleural mass	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.08% 2/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Abdominal neoplasm	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 breast neoplasm	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 neoplasm of bladder	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 uterine neoplasm	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 neoplasm	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 transitional cell carcinoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 recurrent	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Brenner tumour	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Cervix carcinoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Chronic lymphocytic leukaemia	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Chronic myeloid leukaemia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 neoplasm	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Colorectal adenocarcinoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Colorectal cancer metastatic	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Ductal adenocarcinoma of pancreas	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Gastrointestinal cancer metastatic	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Glioblastoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Glioblastoma multiforme	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Large intestine benign neoplasm	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Leukaemia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Leukaemia recurrent	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 cancer metastatic	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 melanoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 neoplasm of unknown primary site	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Meningioma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 central nervous system	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Metastatic carcinoma of the bladder	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Metastatic malignant melanoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Myelodysplastic syndrome	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Myelofibrosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Nasal cavity cancer	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Oesophageal carcinoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Pituitary tumour benign	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Pleomorphic adenoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Polycythaemia vera	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 lung	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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 the tongue	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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) Tonsil cancer	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain oedema	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Brain stem infarction	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Carotid artery stenosis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral haematoma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.34% 8/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.46% 11/2368 • Number of events 12 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral ischaemia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebral thrombosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Diabetic ketoacidotic hyperglycaemic coma	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Embolic stroke	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Epilepsy	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Facial paralysis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Generalised tonic-clonic seizure	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Haemorrhagic stroke	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Haemorrhagic transformation stroke	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Headache	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Iiird nerve paresis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Ischaemic cerebral infarction	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 24/2368 • Number of events 26 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.1% 26/2368 • Number of events 28 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Loss of consciousness	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Nervous system disorder	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Parkinson's disease	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Peroneal nerve palsy	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Post herpetic neuralgia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Presyncope	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Sciatica	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Syncope	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.55% 13/2368 • Number of events 14 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.55% 13/2368 • Number of events 13 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Vascular dementia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Vascular encephalopathy	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Vertebral artery occlusion	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Vertebral artery stenosis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Nervous system disorders Vertebrobasilar insufficiency	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device dislocation	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device failure	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device inappropriate shock delivery	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device lead issue	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Product Issues Device malfunction	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Product Issues Lead dislodgement	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Alcohol withdrawal syndrome	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Anxiety disorder	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Bipolar i disorder	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Completed suicide	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Delirium	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Depression	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Mental status changes	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Psychiatric disorders Suicide attempt	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.97% 23/2368 • Number of events 25 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	1.9% 46/2368 • Number of events 49 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Anuria	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 10 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Cystitis noninfective	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephropathy	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Nephropathy toxic	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Postrenal failure	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Prerenal failure	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal artery stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal colic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal cyst	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal disorder	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.34% 8/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.34% 8/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.55% 13/2368 • Number of events 14 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal injury	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Ureterolithiasis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urethral stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Adenomyosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Orchitis noninfective	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.30% 7/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.59% 14/2368 • Number of events 16 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Aspiration	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.59% 14/2368 • Number of events 16 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.93% 22/2368 • Number of events 34 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.25% 6/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Eosinophilic pneumonia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung cyst	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal lesion	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.17% 4/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.59% 14/2368 • Number of events 14 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 4 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 5 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary vasculitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.30% 7/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Blister	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin necrosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Accelerated hypertension	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Angiodysplasia	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic aneurysm	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic aneurysm rupture	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic dissection	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Aortic stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Circulatory collapse	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.25% 6/2368 • Number of events 7 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Dry gangrene	0.04% 1/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Embolism arterial	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Essential hypertension	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Extremity necrosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Haematocoele	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Haematoma	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertension	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertensive crisis	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.13% 3/2368 • Number of events 3 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertensive emergency	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypertensive urgency	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypotension	0.30% 7/2368 • Number of events 9 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.46% 11/2368 • Number of events 12 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypovolaemic shock	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Iliac artery occlusion	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 6 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral arterial occlusive disease	0.46% 11/2368 • Number of events 11 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.42% 10/2368 • Number of events 11 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral artery occlusion	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.08% 2/2368 • Number of events 2 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral artery stenosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral embolism	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral ischaemia	0.38% 9/2368 • Number of events 11 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.21% 5/2368 • Number of events 8 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Peripheral vascular disorder	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Shock	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Thrombophlebitis superficial	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Thrombosis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Vasculitis	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Venous thrombosis limb	0.04% 1/2368 • Number of events 1 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	0.00% 0/2368 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.

Other adverse events

Measure	Dapa 10mg n=2368 participants at risk Dapagliflozin 10 mg, given once daily per oral use.	Placebo n=2368 participants at risk Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use.
Cardiac disorders Atrial fibrillation	2.4% 58/2368 • Number of events 63 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	2.2% 52/2368 • Number of events 55 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Cardiac disorders Cardiac failure	3.2% 76/2368 • Number of events 90 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	5.5% 130/2368 • Number of events 154 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	2.7% 63/2368 • Number of events 84 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	3.2% 76/2368 • Number of events 100 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	2.7% 63/2368 • Number of events 67 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	2.4% 56/2368 • Number of events 60 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.
Vascular disorders Hypotension	3.7% 88/2368 • Number of events 98 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is used. Safety analysis set : Consisted of all randomized patients who received at least one dose of study drug.	3.1% 73/2368 • Number of events 81 • Up to 28.3 months. For analysis of Adverse Events Safety analysis set is 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