Trial Outcomes & Findings for Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND) (NCT NCT01394952)

NCT ID: NCT01394952

Last Updated: 2019-10-08

Results Overview

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 9901 participants
• Primary outcome timeframe: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)
• Results posted on: 2019-10-08

Participant Flow

Participants were randomized to either placebo or Dulaglutide. Completers included participants for whom vital status was ascertained during the study close-out period and endpoint completers.

Participant milestones

Measure	Placebo Placebo was administered once weekly, subcutaneously	Dulaglutide 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Overall Study STARTED	4952	4949
Overall Study Received at Least One Dose of Study Drug	4949	4943
Overall Study COMPLETED	4935	4932
Overall Study NOT COMPLETED	17	17

Reasons for withdrawal

Measure	Placebo Placebo was administered once weekly, subcutaneously	Dulaglutide 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Overall Study Lost to Follow-up	0	5
Overall Study Withdrawal by Subject	10	5
Overall Study Physician Decision	2	0
Overall Study Sponsor Decision	5	7

Baseline Characteristics

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Baseline characteristics by cohort

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously	Total n=9901 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2315 Participants n=5 Participants	2330 Participants n=7 Participants	4645 Participants n=5 Participants
Age, Categorical >=65 years	2637 Participants n=5 Participants	2619 Participants n=7 Participants	5256 Participants n=5 Participants
Age, Continuous	66.2 years STANDARD_DEVIATION 6.5 • n=5 Participants	66.2 years STANDARD_DEVIATION 6.5 • n=7 Participants	66.2 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	2283 Participants n=5 Participants	2306 Participants n=7 Participants	4589 Participants n=5 Participants
Sex: Female, Male Male	2669 Participants n=5 Participants	2643 Participants n=7 Participants	5312 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	64 Participants n=5 Participants	60 Participants n=7 Participants	124 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	402 Participants n=5 Participants	400 Participants n=7 Participants	802 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4486 Participants n=5 Participants	4489 Participants n=7 Participants	8975 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	543 Participants n=5 Participants	549 Participants n=7 Participants	1092 Participants n=5 Participants
Race (NIH/OMB) Asian	218 Participants n=5 Participants	216 Participants n=7 Participants	434 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) Black or African American	346 Participants n=5 Participants	331 Participants n=7 Participants	677 Participants n=5 Participants
Race (NIH/OMB) White	3744 Participants n=5 Participants	3754 Participants n=7 Participants	7498 Participants n=5 Participants
Race (NIH/OMB) More than one race	79 Participants n=5 Participants	87 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	475 Participants n=5 Participants	468 Participants n=7 Participants	943 Participants n=5 Participants
Region of Enrollment Czechia	107 Participants n=5 Participants	106 Participants n=7 Participants	213 Participants n=5 Participants
Region of Enrollment Russia	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
Region of Enrollment South Korea	62 Participants n=5 Participants	60 Participants n=7 Participants	122 Participants n=5 Participants
Region of Enrollment Sweden	117 Participants n=5 Participants	119 Participants n=7 Participants	236 Participants n=5 Participants
Region of Enrollment Latvia	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment Brazil	137 Participants n=5 Participants	138 Participants n=7 Participants	275 Participants n=5 Participants
Region of Enrollment Poland	305 Participants n=5 Participants	303 Participants n=7 Participants	608 Participants n=5 Participants
Region of Enrollment Chile	64 Participants n=5 Participants	64 Participants n=7 Participants	128 Participants n=5 Participants
Region of Enrollment Bulgaria	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
Region of Enrollment Lithuania	52 Participants n=5 Participants	53 Participants n=7 Participants	105 Participants n=5 Participants
Region of Enrollment Colombia	392 Participants n=5 Participants	393 Participants n=7 Participants	785 Participants n=5 Participants
Region of Enrollment Argentina	698 Participants n=5 Participants	697 Participants n=7 Participants	1395 Participants n=5 Participants
Region of Enrollment Romania	544 Participants n=5 Participants	541 Participants n=7 Participants	1085 Participants n=5 Participants
Region of Enrollment Hungary	113 Participants n=5 Participants	110 Participants n=7 Participants	223 Participants n=5 Participants
Region of Enrollment United Kingdom	65 Participants n=5 Participants	71 Participants n=7 Participants	136 Participants n=5 Participants
Region of Enrollment Spain	62 Participants n=5 Participants	65 Participants n=7 Participants	127 Participants n=5 Participants
Region of Enrollment New Zealand	119 Participants n=5 Participants	115 Participants n=7 Participants	234 Participants n=5 Participants
Region of Enrollment Canada	564 Participants n=5 Participants	564 Participants n=7 Participants	1128 Participants n=5 Participants
Region of Enrollment Taiwan	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment South Africa	369 Participants n=5 Participants	372 Participants n=7 Participants	741 Participants n=5 Participants
Region of Enrollment Mexico	219 Participants n=5 Participants	219 Participants n=7 Participants	438 Participants n=5 Participants
Region of Enrollment Australia	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Region of Enrollment Germany	292 Participants n=5 Participants	293 Participants n=7 Participants	585 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

Outcome measures

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	663 Participants	594 Participants

SECONDARY outcome

Timeframe: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

Outcome measures

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually Death from CV causes	346 Participants	317 Participants
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually Nonfatal MI	212 Participants	205 Participants
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually Nonfatal stroke	175 Participants	135 Participants

SECONDARY outcome

Timeframe: From randomization to study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Outcome measures

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Number of Participants Who Experienced an Event for Time to All-cause Mortality	592 Participants	536 Participants

SECONDARY outcome

Timeframe: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.

Outcome measures

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint	1241 Participants	1099 Participants

SECONDARY outcome

Timeframe: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Outcome measures

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit	226 Participants	213 Participants

SECONDARY outcome

Timeframe: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Outcome measures

Measure	Placebo n=4952 Participants Placebo was administered once weekly, subcutaneously	Dulaglutide n=4949 Participants 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina	77 Participants	88 Participants

Adverse Events

Placebo

Serious events: 2044 serious events

Other events: 3363 other events

Deaths: 592 deaths

Dulaglutide

Serious events: 1991 serious events

Other events: 3574 other events

Deaths: 536 deaths

Serious adverse events

Measure	Placebo n=4949 participants at risk Placebo was administered once weekly, subcutaneously	Dulaglutide n=4943 participants at risk 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Blood and lymphatic system disorders Neutropenia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis streptococcal	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cervicitis	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Normocytic anaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Pancytopenia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Splenic haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Acute coronary syndrome	0.83% 41/4949 • Number of events 43 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.87% 43/4943 • Number of events 44 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Acute left ventricular failure	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Acute myocardial infarction	1.1% 53/4949 • Number of events 59 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.79% 39/4943 • Number of events 40 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Angina pectoris	1.2% 58/4949 • Number of events 67 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.1% 56/4943 • Number of events 61 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Angina unstable	1.1% 54/4949 • Number of events 58 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.89% 44/4943 • Number of events 47 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Aortic valve disease mixed	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Aortic valve incompetence	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cholecystitis infective	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Chronic hepatitis b	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Clostridium colitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Sternal fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Subdural haematoma	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Subdural haemorrhage	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Suture rupture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Traumatic haematoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Traumatic haemothorax	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.2% 33/2667 • Number of events 34 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 33/2640 • Number of events 33 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.15% 4/2667 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 2/2640 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2640 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage i	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia	0.46% 23/4949 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.59% 29/4943 • Number of events 30 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia folate deficiency	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia of malignant disease	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Anaemia vitamin b12 deficiency	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Blood disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Deficiency anaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Febrile neutropenia	0.08% 4/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Haemolytic anaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Histiocytosis haematophagic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Iron deficiency anaemia	0.18% 9/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.28% 14/4943 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Microcytic anaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Nephrogenic anaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Aortic valve stenosis	0.12% 6/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Arrhythmia	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Arteriosclerosis coronary artery	0.18% 9/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial fibrillation	1.3% 62/4949 • Number of events 79 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.8% 90/4943 • Number of events 107 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial flutter	0.36% 18/4949 • Number of events 19 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.30% 15/4943 • Number of events 19 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial tachycardia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrial thrombosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrioventricular block	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrioventricular block complete	0.22% 11/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrioventricular block first degree	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Atrioventricular block second degree	0.18% 9/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bifascicular block	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bradyarrhythmia	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bradycardia	0.20% 10/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.32% 16/4943 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bundle branch block left	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Bundle branch block right	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac arrest	0.28% 14/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.22% 11/4943 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure	2.1% 104/4949 • Number of events 124 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.6% 78/4943 • Number of events 87 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure acute	0.18% 9/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure chronic	0.42% 21/4949 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.28% 14/4943 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac failure congestive	0.95% 47/4949 • Number of events 52 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.77% 38/4943 • Number of events 42 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiac tamponade	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardio-respiratory arrest	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiogenic shock	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiomyopathy	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiomyopathy alcoholic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiopulmonary failure	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiorenal syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiovascular disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cardiovascular insufficiency	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Chronic left ventricular failure	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Congestive cardiomyopathy	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Cor pulmonale	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Coronary artery disease	1.2% 57/4949 • Number of events 64 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 57/4943 • Number of events 63 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Coronary artery insufficiency	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Coronary artery occlusion	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Coronary artery perforation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Defect conduction intraventricular	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Diastolic dysfunction	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Dressler's syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Extrasystoles	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Gastrocardiac syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Hypertensive heart disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Ischaemic cardiomyopathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Left ventricular dysfunction	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Left ventricular failure	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Metabolic cardiomyopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Microvascular coronary artery disease	0.02% 1/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Mitral valve disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Mitral valve incompetence	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Mitral valve prolapse	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Mitral valve stenosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Myocardial infarction	0.71% 35/4949 • Number of events 37 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.61% 30/4943 • Number of events 30 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Myocardial ischaemia	0.46% 23/4949 • Number of events 23 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 19/4943 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Myocarditis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Nodal rhythm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Palpitations	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericardial effusion	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Pericarditis	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Prinzmetal angina	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Right ventricular dysfunction	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Right ventricular failure	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Silent myocardial infarction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinoatrial block	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus arrest	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus bradycardia	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus node dysfunction	0.18% 9/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Stress cardiomyopathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Supraventricular extrasystoles	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Supraventricular tachycardia	0.18% 9/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachyarrhythmia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tachycardia induced cardiomyopathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Tricuspid valve incompetence	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Ventricular arrhythmia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Ventricular extrasystoles	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Ventricular fibrillation	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Ventricular tachycardia	0.10% 5/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Adenomatous polyposis coli	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Atrial septal defect	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Chronic granulomatous disease	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Congenital cerebrovascular anomaly	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Exomphalos	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Heart disease congenital	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Hereditary motor and sensory neuropathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/2667 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 2/2640 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Phimosis	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 3/2640 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Congenital, familial and genetic disorders Vascular malformation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness neurosensory	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Hypoacusis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Sudden hearing loss	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vertigo positional	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vestibular ataxia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Ear and labyrinth disorders Vestibular disorder	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Acromegaly	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Adrenal insufficiency	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Adrenocortical insufficiency acute	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Autoimmune thyroiditis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Cushing's syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Goitre	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.24% 12/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperaldosteronism	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperparathyroidism	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperparathyroidism primary	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperparathyroidism secondary	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hyperthyroidism	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hypoparathyroidism secondary	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Parathyroid disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Primary hyperaldosteronism	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Thyroid mass	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Thyroiditis subacute	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Toxic nodular goitre	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Amaurosis fugax	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Amblyopia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Angle closure glaucoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Blepharochalasis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract	0.59% 29/4949 • Number of events 34 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.38% 19/4943 • Number of events 27 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract diabetic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract nuclear	0.06% 3/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract subcapsular	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Dacryostenosis acquired	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Diabetic retinopathy	0.08% 4/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Diplopia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Eye haemorrhage	0.02% 1/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Glaucoma	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Hypermetropia	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Iridodialysis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Lens dislocation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Macular fibrosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Macular hole	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Macular oedema	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Maculopathy	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Neurotrophic keratopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Open angle glaucoma	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Ophthalmic vein thrombosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Optic ischaemic neuropathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal artery embolism	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal artery occlusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal detachment	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Retinal tear	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Strabismus	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Vitreous haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal adhesions	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal compartment syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal hernia	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal hernia obstructive	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal incarcerated hernia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal mass	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	0.20% 10/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal wall haematoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Acute abdomen	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Anal fistula	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Anal incontinence	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ascites	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Barrett's oesophagus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Chronic gastritis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis	0.14% 7/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis ischaemic	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis microscopic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Crohn's disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dental cyst	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diaphragmatic hernia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticular perforation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticulum	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticulum intestinal	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Duodenal ulcer	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Duodenitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dysphagia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Enteritis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Enterovesical fistula	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Erosive duodenitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Faecaloma	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Fistula of small intestine	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Food poisoning	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gallstone ileus	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric dilatation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric dysplasia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric polyps	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric ulcer	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastritis	0.34% 17/4949 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastritis erosive	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.26% 13/4949 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.24% 12/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal motility disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal mucocoele	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal necrosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal polyp	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal ulcer	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haematemesis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haematochezia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hernial eventration	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Heyde's syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Hiatus hernia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ileus	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ileus paralytic	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Incarcerated inguinal hernia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Incarcerated umbilical hernia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.22% 11/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.34% 17/4943 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal ischaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal mass	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.28% 14/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal perforation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal polyp	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intestinal stenosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Intussusception	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Irritable bowel syndrome	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Large intestine perforation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Large intestine polyp	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Mallory-weiss syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Mechanical ileus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Megacolon	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Melaena	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Mesenteric arterial occlusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Mesenteric artery thrombosis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Mouth haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Necrotising oesophagitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Obstructive pancreatitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal achalasia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal stenosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Palatal disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatic cyst	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatic pseudocyst	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis acute	0.16% 8/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.30% 15/4943 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Peptic ulcer	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Peritoneal adhesions	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Peritoneal haematoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Peritoneal hernia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Portal venous gas	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Proctitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Rectal haemorrhage	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Rectal polyp	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Salivary gland calculus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	0.20% 10/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Spigelian hernia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Strangulated umbilical hernia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Umbilical hernia	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Umbilical hernia, obstructive	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.20% 10/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Varices oesophageal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Volvulus of small bowel	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Adverse drug reaction	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Asthenia	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest discomfort	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest pain	0.28% 14/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Death	0.18% 9/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Device intolerance	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Drug effect increased	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Drug intolerance	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Gait disturbance	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders General physical health deterioration	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Generalised oedema	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Hernia perforation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Hyperthermia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Impaired healing	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Inflammation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Malaise	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Metaplasia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Multiple organ dysfunction syndrome	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Necrosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.75% 37/4949 • Number of events 44 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.53% 26/4943 • Number of events 28 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pain	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Peripheral swelling	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Strangulated hernia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Sudden cardiac death	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Sudden death	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Systemic inflammatory response syndrome	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Vascular stent occlusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Vascular stent stenosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Bile duct obstruction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Bile duct stone	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Biliary colic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Biliary dyspepsia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholangitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholangitis acute	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholangitis chronic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.30% 15/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.51% 25/4943 • Number of events 28 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.34% 17/4949 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.53% 26/4943 • Number of events 27 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis chronic	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.99% 49/4949 • Number of events 51 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.85% 42/4943 • Number of events 43 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholestasis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Drug-induced liver injury	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Gallbladder cholesterolosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Gallbladder necrosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Gallbladder perforation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic cirrhosis	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic failure	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic mass	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic steatosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatitis	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatorenal syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Ischaemic hepatitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Jaundice	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Jaundice cholestatic	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Liver disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Non-alcoholic fatty liver	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Portal hypertension	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Post cholecystectomy syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Anti-neutrophil cytoplasmic antibody positive vasculitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Contrast media allergy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Drug hypersensitivity	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Hypersensitivity	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Immunodeficiency	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Sarcoidosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abdominal abscess	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess intestinal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess limb	0.06% 3/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess neck	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Abscess oral	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Anal abscess	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Anal infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Aortitis salmonella	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendiceal abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis perforated	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Arthritis bacterial	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Arthritis infective	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Atypical pneumonia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bacteraemia	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bacterial infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Biliary sepsis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Brain abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Breast abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Breast cellulitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	0.24% 12/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis bacterial	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis fungal	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis viral	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Burn infection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Campylobacter gastroenteritis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Candida sepsis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Candiduria	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Carbuncle	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cellulitis	0.85% 42/4949 • Number of events 48 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.77% 38/4943 • Number of events 39 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Clostridium difficile colitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Clostridium difficile infection	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Corneal abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cystitis	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cystitis escherichia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Cytomegalovirus colitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Dengue fever	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Dengue haemorrhagic fever	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Device related infection	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Device related sepsis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Diabetic foot infection	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Diabetic gangrene	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Diarrhoea infectious	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Diverticulitis	0.20% 10/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.30% 15/4943 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Dysentery	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Echinococciasis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Empyema	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Endocarditis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Endocarditis bacterial	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Enterococcal sepsis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Enterocolitis bacterial	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Epididymitis	0.00% 0/2667 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.15% 4/2640 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Erysipelas	0.30% 15/4949 • Number of events 18 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.22% 11/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Escherichia bacteraemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Escherichia sepsis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Escherichia urinary tract infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Extradural abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gallbladder abscess	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gallbladder empyema	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gangrene	0.22% 11/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 18 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis	0.20% 10/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.42% 21/4943 • Number of events 22 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis clostridial	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis norovirus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastroenteritis viral	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Gastrointestinal infection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Tendon rupture	0.06% 3/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Genitourinary tract infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Groin abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations H1n1 influenza	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Thermal burn	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Haematoma infection	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Helicobacter gastritis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Helicobacter infection	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hepatitis b	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hepatitis c	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hepatitis e	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hepatitis infectious mononucleosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes zoster	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes zoster meningoencephalitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Herpes zoster pharyngitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Hydrocele male infected	0.00% 0/2667 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2640 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Implant site infection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infected skin ulcer	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infectious colitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.12% 6/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Injection site abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Intervertebral discitis	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Intestinal sepsis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Joint abscess	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Kidney infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Labyrinthitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Laryngitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Liver abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Localised infection	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.22% 11/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.24% 12/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection bacterial	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lung abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lung infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Lymphangitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Mastitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Mastoiditis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Mediastinitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Medical device site infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Medical device site joint infection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Meningitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Meningitis aseptic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Myiasis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Necrotising fasciitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Neutropenic sepsis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Oesophageal candidiasis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Orchitis	0.07% 2/2667 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 3/2640 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Osteomyelitis	0.22% 11/4949 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Osteomyelitis acute	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Osteomyelitis chronic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Otitis externa	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Otitis media chronic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pancreatic abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Paronychia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pelvic abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Tibia fracture	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pelvic infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Perihepatic abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Perineal abscess	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Periodontitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Perirectal abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Peritonitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pharyngeal abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia	3.1% 151/4949 • Number of events 174 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.7% 135/4943 • Number of events 152 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia bacterial	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia influenzal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia klebsiella	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia legionella	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia streptococcal	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pneumonia viral	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Post procedural infection	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Post procedural pneumonia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Post procedural sepsis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Postoperative abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Postoperative wound infection	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pseudomonal sepsis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pulmonary mycosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pulmonary sepsis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pulmonary tuberculosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pyelitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pyelonephritis	0.30% 15/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pyelonephritis acute	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pyelonephritis chronic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Pyonephrosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Renal abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Renal cyst infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Respiratory tract infection	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Salmonella sepsis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Salmonellosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Scrotal infection	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sepsis	0.71% 35/4949 • Number of events 37 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.61% 30/4943 • Number of events 33 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Septic shock	0.44% 22/4949 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.30% 15/4943 • Number of events 16 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Sinusitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin graft infection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Skin infection	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Soft tissue infection	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Staphylococcal bacteraemia	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Staphylococcal infection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Staphylococcal mediastinitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Staphylococcal sepsis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Toxicity to various agents	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Staphylococcal skin infection	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Streptococcal bacteraemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Subcutaneous abscess	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Systemic candida	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tooth abscess	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tracheobronchitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tuberculosis	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Tuberculosis gastrointestinal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	1.2% 61/4949 • Number of events 65 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 64/4943 • Number of events 78 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection bacterial	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection pseudomonal	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urosepsis	0.38% 19/4949 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.49% 24/4943 • Number of events 26 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Vestibular neuronitis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Viraemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Viral infection	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Viral myocarditis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Wound infection	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Wound sepsis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Accident	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Accident at work	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Accidental overdose	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Acetabulum fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Alcohol poisoning	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Anaemia postoperative	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Anastomotic complication	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Transfusion-related acute lung injury	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ankle fracture	0.40% 20/4949 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.42% 21/4943 • Number of events 21 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arterial injury	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod bite	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Back injury	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Brain contusion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Burns second degree	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Burns third degree	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Chemical poisoning	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Clavicle fracture	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Concussion	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Coronary vascular graft occlusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Craniocerebral injury	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Craniofacial fracture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Facial bones fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Failure to anastomose	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fall	2.5% 124/4949 • Number of events 137 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.2% 110/4943 • Number of events 123 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Femoral neck fracture	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Femur fracture	0.42% 21/4949 • Number of events 22 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.36% 18/4943 • Number of events 18 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Fibula fracture	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Forearm fracture	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Foreign body	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Foreign body aspiration	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Gastrointestinal injury	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Graft thrombosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Hand fracture	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Head injury	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Hip fracture	0.34% 17/4949 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.24% 12/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Humerus fracture	0.40% 20/4949 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.24% 12/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Hyphaema	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Incisional hernia	0.12% 6/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Incisional hernia, obstructive	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Intentional overdose	0.02% 1/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Joint dislocation	0.08% 4/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Joint injury	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Laceration	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament rupture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Limb crushing injury	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Lower limb fracture	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Lumbosacral plexus injury	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Meniscus injury	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.24% 12/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Multiple fractures	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Multiple injuries	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Muscle rupture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Traumatic fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Muscle strain	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Overdose	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Patella fracture	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Pelvic fracture	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Periprosthetic fracture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post concussion syndrome	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural complication	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural discharge	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural haematoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural haematuria	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural swelling	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Postoperative adhesion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Postoperative delirium	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Procedural pain	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Pubis fracture	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Radiation pneumonitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Radius fracture	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.28% 14/4949 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Road traffic accident	0.18% 9/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Sciatic nerve injury	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Scrotal haematoma	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skin injury	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skull fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Soft tissue injury	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Spinal fracture	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Stab wound	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Ulna fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Upper limb fracture	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Vascular graft occlusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Wound	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Wound dehiscence	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Wound secretion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Wrist fracture	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Amylase increased	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Anticoagulation drug level above therapeutic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood calcitonin increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood calcium increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood glucose decreased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood glucose fluctuation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood glucose increased	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood pressure increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations C-reactive protein increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Coagulation test abnormal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Electrocardiogram abnormal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Glomerular filtration rate decreased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Glycosylated haemoglobin increased	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Haemoglobin decreased	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Hepatic enzyme increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Oxygen saturation decreased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Transaminases increased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Troponin increased	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Troponin t increased	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Urine albumin/creatinine ratio increased	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight decreased	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Abnormal loss of weight	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Cachexia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	0.28% 14/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.47% 23/4943 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Failure to thrive	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Fluid overload	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Food intolerance	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Gout	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	1.4% 67/4949 • Number of events 75 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.93% 46/4943 • Number of events 52 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	0.24% 12/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperosmolar state	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 72/4949 • Number of events 80 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.3% 62/4943 • Number of events 69 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	0.22% 11/4949 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Iron deficiency	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Ketoacidosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Lactic acidosis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Metabolic acidosis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Obesity	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthropathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Articular calcification	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.18% 9/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bone lesion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Bursitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondromalacia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Chondropathy	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Costochondritis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Diabetic amyotrophy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Diabetic arthropathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Fracture malunion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Gouty tophus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.42% 21/4949 • Number of events 22 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.30% 15/4943 • Number of events 16 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint ankylosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint noise	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Joint swelling	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.22% 11/4949 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Mobility decreased	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscle spasms	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteitis deformans	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.2% 110/4949 • Number of events 128 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 136/4943 • Number of events 155 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoporosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Periarthritis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Plantar fascial fibromatosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.20% 10/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.42% 21/4949 • Number of events 23 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.32% 16/4943 • Number of events 19 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal pain	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spondylitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Spondylolysis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Synovial cyst	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendon disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tendonitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.20% 10/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.28% 14/4949 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.34% 17/4943 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of the cervix	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell carcinoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic astrocytoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage i	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage ii	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.22% 11/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastric neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hepatic neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct adenocarcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage i	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.22% 11/4943 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage iii	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brenner tumour	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral haemangioma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.17% 4/2303 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2303 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.16% 8/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage ii	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage iv	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large b-cell lymphoma stage iv	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.39% 9/2282 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 6/2303 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.13% 3/2303 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone b-cell lymphoma (malt type)	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder squamous cell carcinoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal cancer	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic angiosarcoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Huerthle cell carcinoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.22% 11/4949 • Number of events 11 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma metastatic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage ii	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage iii	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage iv	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant joint neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage iii	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of vater	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningeal neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to chest wall	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to kidney	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pelvis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal sinus cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/2667 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.11% 3/2640 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage ii	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage iv	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2303 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2303 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2303 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage iii	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2303 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraganglion neoplasm	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell leukaemia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.11% 3/2667 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.23% 6/2640 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle cell sarcoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.14% 7/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.06% 3/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vagina	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the vulva	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sweat gland tumour	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat cancer	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue carcinoma stage iv	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma recurrent	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour of ampulla of vater	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.17% 4/2303 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.13% 3/2303 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine neoplasm	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vascular neoplasm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Acoustic neuritis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Altered state of consciousness	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Amnesia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Amputation stump pain	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Aphasia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ataxia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Autonomic nervous system imbalance	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Balance disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Basal ganglia haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Brain injury	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Brain stem haemorrhage	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Brain stem infarction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carotid arteriosclerosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carotid artery occlusion	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carotid artery stenosis	0.18% 9/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carotid sinus syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Carpal tunnel syndrome	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cauda equina syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebellar ataxia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebellar atrophy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebellar infarction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral arteriosclerosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral atrophy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral circulatory failure	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral haematoma	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral haemorrhage	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral infarction	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral ischaemia	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.63% 31/4949 • Number of events 34 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.49% 24/4943 • Number of events 25 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular insufficiency	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cervical radiculopathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cervicobrachial syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cognitive disorder	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Coma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dementia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dementia alzheimer's type	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Depressed level of consciousness	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic coma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic hyperglycaemic coma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic hyperosmolar coma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic mononeuropathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Diabetic neuropathy	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness postural	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dysarthria	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Embolic stroke	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Encephalopathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Epilepsy	0.16% 8/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Facial paralysis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Frontal lobe epilepsy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Generalised tonic-clonic seizure	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Guillain-barre syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Haemorrhage intracranial	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Haemorrhagic cerebral infarction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Haemorrhagic stroke	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hemiparesis	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hemiplegia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hepatic encephalopathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hydrocephalus	0.08% 4/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypertensive encephalopathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Hypoaesthesia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Iiird nerve paralysis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Intracranial aneurysm	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Intracranial haematoma	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ischaemic cerebral infarction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ischaemic neuropathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Ischaemic stroke	0.36% 18/4949 • Number of events 22 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.28% 14/4943 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Lacunar infarction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Lacunar stroke	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Language disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Loss of consciousness	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Lumbar radiculopathy	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Metabolic encephalopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Migraine	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Mixed dementia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Monoparesis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Motor neurone disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Myasthenia gravis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Myelopathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Myoclonus	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Nerve root compression	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Nervous system disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuritis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Normal pressure hydrocephalus	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Optic neuritis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Paralysis recurrent laryngeal nerve	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Parkinson's disease	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Parkinsonism	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Partial seizures	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Peripheral nerve paresis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Peripheral sensorimotor neuropathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Peroneal nerve palsy	0.04% 2/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Piriformis syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Polyneuropathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Post herpetic neuralgia	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Presyncope	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Pseudobulbar palsy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Psychomotor hyperactivity	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Quadriplegia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Radiculopathy	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sciatica	0.14% 7/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Seizure	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Sensory disturbance	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Serotonin syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Spinal claudication	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Syncope	0.67% 33/4949 • Number of events 34 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.73% 36/4943 • Number of events 38 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Thrombotic stroke	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Toxic encephalopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Transient global amnesia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.46% 23/4949 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.45% 22/4943 • Number of events 25 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Tremor	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Trigeminal neuralgia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Uraemic encephalopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vascular dementia	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vascular encephalopathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vascular parkinsonism	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vertebrobasilar insufficiency	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Vith nerve paralysis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Wernicke's encephalopathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Product Issues Device damage	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Product Issues Device dislocation	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Product Issues Device failure	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Product Issues Device loosening	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Product Issues Device malfunction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Product Issues Device occlusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Abnormal behaviour	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Adjustment disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Adjustment disorder with depressed mood	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Affective disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Aggression	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Alcohol abuse	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Alcohol withdrawal syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Anxiety disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Bipolar disorder	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Confusional state	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Delirium	0.16% 8/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Delusion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression	0.14% 7/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Depression suicidal	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Disorientation	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Emotional distress	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Hypomania	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Major depression	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mania	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mental disorder	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Mental status changes	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Panic disorder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Personality change due to a general medical condition	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Psychogenic seizure	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Psychotic disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Restlessness	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Somatic delusion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Somatic symptom disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicidal ideation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Psychiatric disorders Suicide attempt	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	1.4% 67/4949 • Number of events 74 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.2% 61/4943 • Number of events 72 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Atonic urinary bladder	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Azotaemia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder dysfunction	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder fibrosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder hypertrophy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder mass	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder neck obstruction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder neck sclerosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder obstruction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder outlet obstruction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Bladder pain	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Calculus bladder	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Calculus urethral	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Calculus urinary	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Chronic kidney disease	0.38% 19/4949 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Diabetic nephropathy	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders End stage renal disease	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.14% 7/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Haemorrhage urinary tract	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hydronephrosis	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hydroureter	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hypertensive nephropathy	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Hypertonic bladder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Kidney perforation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.34% 17/4949 • Number of events 18 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.36% 18/4943 • Number of events 19 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Nephropathy	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Pelvi-ureteric obstruction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Proteinuria	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal colic	0.12% 6/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal cyst	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal failure	0.34% 17/4949 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.32% 16/4943 • Number of events 16 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal haematoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal impairment	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.14% 7/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal infarct	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Renal mass	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureteric dilatation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureteric stenosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Ureterolithiasis	0.18% 9/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urethral caruncle	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urethral disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urethral stenosis	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary incontinence	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary retention	0.18% 9/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Urinary tract obstruction	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Acquired phimosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.67% 18/2667 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.80% 21/2640 • Number of events 21 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Breast pain	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Cervical polyp	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Cystocele	0.18% 4/2282 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.13% 3/2303 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Endometrial hypertrophy	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Endometriosis	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Erectile dysfunction	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Fibrocystic breast disease	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Genital prolapse	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/2667 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 2/2640 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Ovarian cyst	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 6/2303 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Pelvic fluid collection	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Prostatism	0.07% 2/2667 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Prostatitis	0.07% 2/2667 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.15% 4/2640 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Prostatomegaly	0.04% 1/2667 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2640 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Rectocele	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Uterine disorder	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Uterine polyp	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.13% 3/2303 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.13% 3/2303 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Uterovaginal prolapse	0.09% 2/2282 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vaginal haemorrhage	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 1/2303 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vaginal polyp	0.04% 1/2282 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/2303 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/2282 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.09% 2/2303 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.34% 17/4949 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Aspiration	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Asthma	0.16% 8/4949 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchial polyp	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.71% 35/4949 • Number of events 45 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.51% 25/4943 • Number of events 32 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.30% 15/4949 • Number of events 15 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.22% 11/4943 • Number of events 12 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Emphysema	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.10% 5/4943 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.16% 8/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.26% 13/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural thickening	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.42% 21/4949 • Number of events 22 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.45% 22/4943 • Number of events 23 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.40% 20/4949 • Number of events 20 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.40% 20/4949 • Number of events 22 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.32% 16/4943 • Number of events 16 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis hypertrophic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Angioedema	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Diabetic foot	0.38% 19/4949 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.28% 14/4943 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Diabetic neuropathic ulcer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Ischaemic skin ulcer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Neuropathic ulcer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pemphigoid	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Psoriasis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash generalised	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin disorder	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin ulcer	0.30% 15/4949 • Number of events 16 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Urticaria	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Vasculitic ulcer	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Social circumstances Diet noncompliance	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Social circumstances Organ donor	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Angiodysplasia	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Aortic aneurysm	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.20% 10/4943 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Aortic aneurysm rupture	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Aortic arteriosclerosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Aortic dissection	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Aortic stenosis	0.32% 16/4949 • Number of events 17 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.42% 21/4943 • Number of events 21 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Arterial occlusive disease	0.06% 3/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Arterial stenosis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Arteriosclerosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Bleeding varicose vein	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Circulatory collapse	0.12% 6/4949 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Deep vein thrombosis	0.20% 10/4949 • Number of events 10 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.32% 16/4943 • Number of events 16 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Dry gangrene	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Essential hypertension	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Extremity necrosis	0.06% 3/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Haematoma	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Haemodynamic instability	0.02% 1/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Haemorrhage	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	0.55% 27/4949 • Number of events 29 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.45% 22/4943 • Number of events 24 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertensive crisis	0.42% 21/4949 • Number of events 21 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.28% 14/4943 • Number of events 14 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertensive emergency	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.08% 4/4943 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypotension	0.14% 7/4949 • Number of events 7 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypovolaemic shock	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Iliac artery embolism	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Intermittent claudication	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Lymphatic fistula	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Lymphoedema	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Neurogenic shock	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Orthostatic hypotension	0.10% 5/4949 • Number of events 5 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.12% 6/4943 • Number of events 6 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.51% 25/4949 • Number of events 26 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.34% 17/4943 • Number of events 18 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral artery occlusion	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral artery stenosis	0.06% 3/4949 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral artery thrombosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral embolism	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral ischaemia	0.16% 8/4949 • Number of events 9 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.18% 9/4943 • Number of events 13 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral vascular disorder	0.14% 7/4949 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.16% 8/4943 • Number of events 8 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Peripheral venous disease	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Phlebitis	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Shock	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Shock haemorrhagic	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Subclavian artery stenosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Superior vena cava syndrome	0.00% 0/4949 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.02% 1/4943 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Temporal arteritis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Thrombophlebitis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Thrombosis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Varicose vein	0.08% 4/4949 • Number of events 4 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.06% 3/4943 • Number of events 3 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Vena cava thrombosis	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Venous thrombosis	0.04% 2/4949 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/4943 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Venous thrombosis limb	0.02% 1/4949 • Number of events 1 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.04% 2/4943 • Number of events 2 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Measure	Placebo n=4949 participants at risk Placebo was administered once weekly, subcutaneously	Dulaglutide n=4943 participants at risk 1.5 mg Dulaglutide was administered once weekly, subcutaneously
Eye disorders Cataract	7.4% 368/4949 • Number of events 417 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.3% 363/4943 • Number of events 427 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	4.2% 208/4949 • Number of events 223 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.3% 361/4943 • Number of events 409 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	8.8% 436/4949 • Number of events 546 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	13.5% 665/4943 • Number of events 843 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	3.0% 147/4949 • Number of events 150 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.9% 291/4943 • Number of events 331 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	5.4% 269/4949 • Number of events 310 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	14.9% 735/4943 • Number of events 968 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	3.1% 154/4949 • Number of events 165 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.6% 325/4943 • Number of events 498 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Bronchitis	8.5% 421/4949 • Number of events 554 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.3% 408/4943 • Number of events 528 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	8.2% 404/4949 • Number of events 488 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 369/4943 • Number of events 435 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	10.8% 535/4949 • Number of events 771 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.4% 564/4943 • Number of events 800 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	8.2% 407/4949 • Number of events 589 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.4% 368/4943 • Number of events 533 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Urinary tract infection	10.4% 517/4949 • Number of events 749 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	11.0% 545/4943 • Number of events 795 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	2.1% 104/4949 • Number of events 109 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.6% 325/4943 • Number of events 379 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	6.4% 315/4949 • Number of events 445 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.2% 158/4943 • Number of events 190 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	7.2% 354/4949 • Number of events 1160 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.4% 413/4943 • Number of events 1477 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 389/4949 • Number of events 469 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.5% 371/4943 • Number of events 446 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	8.4% 416/4949 • Number of events 484 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.0% 447/4943 • Number of events 494 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	6.4% 318/4949 • Number of events 373 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.7% 329/4943 • Number of events 372 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 245/4949 • Number of events 280 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 260/4943 • Number of events 296 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	6.0% 296/4949 • Number of events 339 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.4% 318/4943 • Number of events 373 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	5.8% 288/4949 • Number of events 382 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	6.6% 324/4943 • Number of events 414 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Microalbuminuria	5.2% 259/4949 • Number of events 263 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.7% 232/4943 • Number of events 241 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	5.1% 135/2667 • Number of events 137 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.3% 140/2640 • Number of events 144 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 256/4949 • Number of events 292 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.8% 239/4943 • Number of events 265 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	8.7% 432/4949 • Number of events 491 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.0% 345/4943 • Number of events 405 • From Randomization to Study Completion (Up to 7 Years) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: www.ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60