Trial Outcomes & Findings for IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103) (NCT NCT00202878)

NCT ID: NCT00202878

Last Updated: 2024-06-18

Results Overview

The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction \[MI\], documented unstable angina \[UA\] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18144 participants

Primary outcome timeframe

Up to approximately 9 years

Results posted on

2024-06-18

Participant Flow

Adult men and women presenting with non-ST segment elevation myocardial infarction (NSTEMI) , STEMI, or hospitalized, documented unstable angina (UA) whom a percutaneous coronary intervention (PCI) was planned as management for the qualifying acute coronary syndrome (ACS) event were eligible for entry into the trial.

Study continued until a minimum of 5,250 participants had a primary endpoint event and each participant was followed for a minimum of 2.5 years.

Participant milestones

Participant milestones
Measure	Ezetimibe/Simvastatin One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.	Simvastatin One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
Overall Study STARTED	9067	9077
Overall Study COMPLETED	6868	6860
Overall Study NOT COMPLETED	2199	2217

Reasons for withdrawal

Reasons for withdrawal
Measure	Ezetimibe/Simvastatin One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.	Simvastatin One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
Overall Study Death	964	968
Overall Study Only Vital Status Known	357	356
Overall Study Lost to Follow-up	44	49
Overall Study Site Closure	39	36
Overall Study Withdrawal by Subject	795	808

Baseline Characteristics

IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ezetimibe/Simvastatin n=9067 Participants One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.	Simvastatin n=9077 Participants One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.	Total n=18144 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 9.7 • n=5 Participants	63.6 years STANDARD_DEVIATION 9.8 • n=7 Participants	63.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	2225 Participants n=5 Participants	2191 Participants n=7 Participants	4416 Participants n=5 Participants
Sex: Female, Male Male	6842 Participants n=5 Participants	6886 Participants n=7 Participants	13728 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 9 years

Population: All participants who were randomly assigned to a treatment arm.

The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction \[MI\], documented unstable angina \[UA\] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization.

Outcome measures

Outcome measures
Measure	Simvastatin n=9077 Participants One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.	Ezetimibe/Simvastatin n=9067 Participants One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)	34.67 Percentage of Participants Interval 33.56 to 35.81	32.72 Percentage of Participants Interval 31.63 to 33.85

SECONDARY outcome

Timeframe: Up to approximately 9 years

Population: All participants who were randomly assigned to a treatment arm.

The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization.

Outcome measures

Outcome measures
Measure	Simvastatin n=9077 Participants One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.	Ezetimibe/Simvastatin n=9067 Participants One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)	40.25 Percentage of Participants Interval 39.11 to 41.41	38.65 Percentage of Participants Interval 37.52 to 39.81

SECONDARY outcome

Timeframe: Up to approximately 9 years

Population: All participants who were randomly assigned to a treatment arm.

The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization.

Outcome measures

Outcome measures
Measure	Simvastatin n=9077 Participants One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.	Ezetimibe/Simvastatin n=9067 Participants One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)	18.88 Percentage of Participants Interval 17.96 to 19.83	17.52 Percentage of Participants Interval 16.62 to 18.46

SECONDARY outcome

Timeframe: Up to approximately 9 years

Population: All participants who were randomly assigned to a treatment arm.

The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization.

Outcome measures

Outcome measures
Measure	Simvastatin n=9077 Participants One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.	Ezetimibe/Simvastatin n=9067 Participants One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)	36.20 Percentage of Participants Interval 35.07 to 37.34	34.49 Percentage of Participants Interval 33.38 to 35.63

Adverse Events

Ezetimide/Simvastatin

Serious events: 3640 serious events

Other events: 5486 other events

Deaths: 0 deaths

Simvastatin

Serious events: 3649 serious events

Other events: 5472 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ezetimide/Simvastatin n=9067 participants at risk One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.	Simvastatin n=9077 participants at risk One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
Infections and infestations Cholecystitis Infective	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Chronic Sinusitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Clostridium Difficile Colitis	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Clostridium Difficile Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Clostridium Difficile Sepsis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Coccidioidomycosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Colonic Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Cystitis	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Dengue Fever	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Device Related Infection	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Adenoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Agranulocytosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Anaemia	0.78% 71/9067 • Number of events 71 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.61% 55/9077 • Number of events 55 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Anaemia Macrocytic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Anaemia Megaloblastic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Anaemia Of Chronic Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Anaemia Of Malignant Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Coagulopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Febrile Neutropenia	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Haemolytic Anaemia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Haemorrhagic Diathesis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Heparin-Induced Thrombocytopenia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Hilar Lymphadenopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Hypercoagulation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Hypereosinophilic Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Hypochromic Anaemia	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Immune Thrombocytopenic Purpura	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Leukocytosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Leukopenia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Lymphadenopathy	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Lymphadenopathy Mediastinal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Lymphoid Tissue Hyperplasia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Microcytic Anaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Normochromic Normocytic Anaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Pancytopenia	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Retroperitoneal Lymphadenopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Splenic Lesion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Splenic Vein Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Systemic Mastocytosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Thrombocytopenia	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Blood and lymphatic system disorders Thrombocytopenic Purpura	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Adams-Stokes Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Angina Pectoris	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Aortic Valve Incompetence	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Aortic Valve Stenosis	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Arrhythmia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Arrhythmia Supraventricular	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrial Fibrillation	1.5% 140/9067 • Number of events 140 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.7% 150/9077 • Number of events 150 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrial Flutter	0.26% 24/9067 • Number of events 24 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.31% 28/9077 • Number of events 28 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrial Tachycardia	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrial Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrioventricular Block	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrioventricular Block Complete	0.14% 13/9067 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrioventricular Block First Degree	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrioventricular Block Second Degree	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Atrioventricular Dissociation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Bradyarrhythmia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Bradycardia	0.30% 27/9067 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.33% 30/9077 • Number of events 30 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Bundle Branch Block	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Bundle Branch Block Left	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiac Aneurysm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiac Arrest	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiac Failure	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiac Pseudoaneurysm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiac Tamponade	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiac Ventricular Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardio-Respiratory Arrest	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiogenic Shock	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiomyopathy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiorenal Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cardiovascular Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Chronotropic Incompetence	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Conduction Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Congestive Cardiomyopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Cor Pulmonale	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Coronary Artery Dissection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Coronary Artery Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Coronary Artery Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Dressler's Syndrome	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Extrasystoles	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Heart Valve Incompetence	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Hypertensive Cardiomyopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Intracardiac Thrombus	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Ischaemic Cardiomyopathy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Left Ventricular Dysfunction	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Mitral Valve Incompetence	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Mitral Valve Stenosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Myocardial Ischaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Myocarditis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Palpitations	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Pericardial Effusion	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Pericardial Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Pericarditis	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Pericarditis Constrictive	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Sick Sinus Syndrome	0.19% 17/9067 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.21% 19/9077 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Sinus Arrest	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Sinus Arrhythmia	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Sinus Bradycardia	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Sinus Tachycardia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Supraventricular Extrasystoles	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Supraventricular Tachyarrhythmia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Supraventricular Tachycardia	0.18% 16/9067 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Tachycardia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Tachycardia Paroxysmal	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Torsade De Pointes	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Trifascicular Block	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Ventricular Arrhythmia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Ventricular Extrasystoles	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Ventricular Fibrillation	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Ventricular Tachycardia	0.32% 29/9067 • Number of events 29 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.46% 42/9077 • Number of events 42 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Cardiac disorders Wolff-Parkinson-White Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Adenomatous Polyposis Coli	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Arteriovenous Malformation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Atrial Septal Defect	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Bicuspid Aortic Valve	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Congenital Spinal Cord Anomaly	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Dermoid Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Epidermal Naevus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Foramen Magnum Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Gastrointestinal Arteriovenous Malformation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Hydrocele	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Hypertrophic Cardiomyopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Multiple Lentigines Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Phimosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Sickle Cell Anaemia With Crisis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Congenital, familial and genetic disorders Ventricular Septal Defect	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Deafness	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Deafness Neurosensory	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Deafness Unilateral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Inner Ear Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Inner Ear Inflammation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Middle Ear Effusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Otorrhoea	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Sudden Hearing Loss	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Tinnitus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Vertigo	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.28% 25/9077 • Number of events 25 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Ear and labyrinth disorders Vertigo Positional	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Adrenal Insufficiency	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Adrenal Mass	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Basedow's Disease	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Goitre	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Hyperparathyroidism	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Hyperparathyroidism Primary	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Hyperthyroidism	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Hypothyroidism	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Inappropriate Antidiuretic Hormone Secretion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Pituitary Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Postpartum Hypopituitarism	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Thyroid Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Thyroid Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Thyroid Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Endocrine disorders Toxic Nodular Goitre	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Blepharitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Blindness	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Blindness Transient	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Cataract	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.19% 17/9077 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Cataract Nuclear	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Corneal Scar	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Diabetic Retinopathy	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Diplopia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Exfoliation Glaucoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Eye Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Eye Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Glaucoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Hyphaema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Lens Dislocation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Macular Degeneration	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Macular Oedema	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Optic Ischaemic Neuropathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Papilloedema	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Retinal Artery Occlusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Retinal Detachment	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Retinal Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Visual Impairment	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Vitreous Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Eye disorders Vitreous Haemorrhage	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Adhesions	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Discomfort	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Distension	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Hernia	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Mass	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Pain	0.45% 41/9067 • Number of events 41 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.47% 43/9077 • Number of events 43 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Pain Lower	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Pain Upper	0.23% 21/9067 • Number of events 21 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Wall Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Abdominal Wall Haematoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Fissure	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Fistula	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Polyp	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Prolapse	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Anal Ulcer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Ascites	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Barrett's Oesophagus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Bezoar	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Bowel Movement Irregularity	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Coeliac Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Colitis	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Colitis Ischaemic	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Colitis Ulcerative	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Constipation	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.17% 15/9077 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Crohn's Disease	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Cyclic Vomiting Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Dental Caries	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diabetic Gastroparesis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diaphragmatic Hernia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diarrhoea	0.25% 23/9067 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.17% 15/9077 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diarrhoea Haemorrhagic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diverticular Perforation	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diverticulitis Intestinal Haemorrhagic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diverticulum	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diverticulum Intestinal	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diverticulum Intestinal Haemorrhagic	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Diverticulum Oesophageal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Duodenal Polyp	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Duodenal Ulcer	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Duodenal Ulcer Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Duodenitis	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Duodenogastric Reflux	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Dyspepsia	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Dysphagia	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Enteritis	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Enterocele	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Enterocolitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Enterocolitis Haemorrhagic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Enterovesical Fistula	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Epigastric Discomfort	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Erosive Duodenitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Erosive Oesophagitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Faecal Incontinence	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Faecaloma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Femoral Hernia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Food Poisoning	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Haemorrhage	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Polyps	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Ulcer	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastric Ulcer Perforation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastritis	0.32% 29/9067 • Number of events 29 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.43% 39/9077 • Number of events 39 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastritis Erosive	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastritis Haemorrhagic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastroduodenal Ulcer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Angiodysplasia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Disorder	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.66% 60/9067 • Number of events 60 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.71% 64/9077 • Number of events 64 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Hypomotility	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Necrosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Obstruction	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Oedema	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Pain	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Perforation	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrointestinal Ulcer Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.30% 27/9067 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.36% 33/9077 • Number of events 33 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Gingival Bleeding	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Haematemesis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Haematochezia	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Haemorrhoids	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Haemorrhoids Thrombosed	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Hernial Eventration	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Hiatus Hernia	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Hypertrophic Anal Papilla	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Ileal Ulcer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Ileus	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Ileus Paralytic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Impaired Gastric Emptying	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Inflammatory Bowel Disease	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Inguinal Hernia	0.76% 69/9067 • Number of events 69 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.56% 51/9077 • Number of events 51 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Inguinal Hernia, Obstructive	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Dilatation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Fistula	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Haematoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Infarction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Ischaemia	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Mass	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Obstruction	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Perforation	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Polyp	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Intestinal Stenosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Irritable Bowel Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Large Intestinal Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Large Intestinal Stenosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Large Intestinal Ulcer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Large Intestine Perforation	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Large Intestine Polyp	0.44% 40/9067 • Number of events 40 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.64% 58/9077 • Number of events 58 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.18% 16/9067 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Lumbar Hernia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Mallory-Weiss Syndrome	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Melaena	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Mesenteric Artery Embolism	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Mesenteric Artery Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Mesenteritis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Mouth Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Mouth Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Nausea	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oedematous Pancreatitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Achalasia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Motility Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Obstruction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Perforation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Rupture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Spasm	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophageal Ulcer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oesophagitis	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Oral Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatic Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatic Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatic Mass	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatic Pseudocyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatitis	0.39% 35/9067 • Number of events 35 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.31% 28/9077 • Number of events 28 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatitis Acute	0.14% 13/9067 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.19% 17/9077 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatitis Chronic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatitis Necrotising	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pancreatitis Relapsing	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Parotid Gland Enlargement	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Peptic Ulcer	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Peritoneal Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pharyngo-Oesophageal Diverticulum	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pneumatosis Intestinalis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Pneumoperitoneum	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Proctalgia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Rectal Haemorrhage	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.19% 17/9077 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Rectal Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Rectal Polyp	0.19% 17/9067 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Rectal Prolapse	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Rectal Ulcer Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Rectourethral Fistula	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Reflux Gastritis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Retroperitoneal Haematoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Retroperitoneal Haemorrhage	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Salivary Gland Calculus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Small Intestinal Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Small Intestinal Obstruction	0.14% 13/9067 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Splenic Artery Aneurysm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Subileus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Tongue Dysplasia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Umbilical Hernia	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Umbilical Hernia, Obstructive	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.29% 26/9067 • Number of events 26 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.28% 25/9077 • Number of events 25 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Volvulus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Gastrointestinal disorders Vomiting	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Adverse Drug Reaction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Adverse Event	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Adverse Reaction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Asthenia	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Brca2 Gene Mutation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Catheter Site Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Chest Discomfort	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Chest Pain	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Chills	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Complication Of Device Insertion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Cyst	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Cyst Rupture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Battery Issue	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Breakage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Dislocation	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Failure	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Issue	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Lead Damage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Lead Issue	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Malfunction	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Device Occlusion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Discomfort	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Drug Withdrawal Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Fat Necrosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Fatigue	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Feeling Cold	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Feeling Hot	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Fibrosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Gait Disturbance	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders General Physical Health Deterioration	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Generalised Oedema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Granuloma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Hernia	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Hernia Obstructive	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Hyperplasia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Hypothermia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Impaired Healing	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Implant Site Extravasation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Implant Site Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Inflammation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Influenza Like Illness	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Injection Site Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Local Swelling	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Malaise	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Medical Device Complication	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Metaplasia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Mucosal Inflammation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Multi-Organ Failure	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Necrosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Non-Cardiac Chest Pain	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Oedema Peripheral	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Pacemaker Generated Arrhythmia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Pacemaker Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Pain	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Pelvic Mass	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Polyp	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Puncture Site Haemorrhage	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Pyrexia	0.26% 24/9067 • Number of events 24 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Stent-Graft Endoleak	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Submandibular Mass	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Systemic Inflammatory Response Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Thrombosis In Device	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Ulcer	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Ulcer Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Xerosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Alcoholic Liver Disease	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Bile Duct Obstruction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Bile Duct Stenosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Bile Duct Stone	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Biliary Colic	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Biliary Dyskinesia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Biliary Tract Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholangitis	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholangitis Acute	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholecystitis	0.52% 47/9067 • Number of events 47 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.80% 73/9077 • Number of events 73 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholecystitis Acute	0.30% 27/9067 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.29% 26/9077 • Number of events 26 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholecystitis Chronic	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholelithiasis	0.86% 78/9067 • Number of events 78 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.78% 71/9077 • Number of events 71 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cholestasis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Cirrhosis Alcoholic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Drug-Induced Liver Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Gallbladder Cholesterolosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Gallbladder Disorder	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Gallbladder Pain	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Gallbladder Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Gallbladder Polyp	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Granulomatous Liver Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatic Cirrhosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatic Cyst	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatic Failure	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatic Mass	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatitis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hepatorenal Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hydrocholecystis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Hyperbilirubinaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Ischaemic Hepatitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Jaundice	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Jaundice Cholestatic	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Liver Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Portal Hypertension	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Hepatobiliary disorders Portal Vein Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Allergy To Arthropod Sting	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Anaphylactic Reaction	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Anaphylactic Shock	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Autoimmune Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Drug Hypersensitivity	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Hypersensitivity	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Immune system disorders Seasonal Allergy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abdominal Abscess	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abdominal Sepsis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abdominal Wall Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abdominal Wall Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abscess Intestinal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abscess Jaw	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abscess Limb	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abscess Neck	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Abscess Oral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Acute Sinusitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Alpha Haemolytic Streptococcal Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Anal Abscess	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Appendiceal Abscess	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Appendicitis	0.36% 33/9067 • Number of events 33 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Appendicitis Perforated	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Arthritis Bacterial	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Arthritis Infective	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bacteraemia	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bacterial Infection	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bacterial Sepsis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Biliary Sepsis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Blister Infected	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Brain Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Breast Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bronchiolitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bronchitis	0.54% 49/9067 • Number of events 49 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.47% 43/9077 • Number of events 43 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bronchitis Bacterial	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bronchitis Viral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bronchopneumonia	0.19% 17/9067 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Campylobacter Gastroenteritis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Campylobacter Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Candida Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Cardiac Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Cellulitis	0.54% 49/9067 • Number of events 49 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.69% 63/9077 • Number of events 63 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Cellulitis Of Male External Genital Organ	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Diabetic Foot Infection	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Diabetic Gangrene	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Diarrhoea Infectious	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Diverticulitis	0.37% 34/9067 • Number of events 34 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.41% 37/9077 • Number of events 37 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Ear Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Echinococciasis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Emphysematous Cholecystitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Empyema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Encephalitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Encephalitis Viral	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Endocarditis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Endocarditis Bacterial	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Endocarditis Enterococcal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Endophthalmitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Epidemic Nephropathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Epididymitis	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Epiglottitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Erysipelas	0.20% 18/9067 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Escherichia Bacteraemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Extradural Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Febrile Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Folliculitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Fungal Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Fungal Skin Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Furuncle	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gallbladder Empyema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gangrene	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastroenteritis	0.56% 51/9067 • Number of events 51 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.48% 44/9077 • Number of events 44 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastroenteritis Bacterial	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastroenteritis Norovirus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastroenteritis Rotavirus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastroenteritis Salmonella	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastroenteritis Viral	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastrointestinal Candidiasis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gastrointestinal Infection	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Gingival Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Graft Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Groin Abscess	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Groin Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations H1n1 Influenza	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Hand-Foot-And-Mouth Disease	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Helicobacter Gastritis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Hepatitis B	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Hepatitis C	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Herpes Simplex Encephalitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Herpes Zoster	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Hiv Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Implant Site Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Incision Site Cellulitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Incision Site Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Incisional Hernia Gangrenous	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infected Bites	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infected Cyst	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infected Dermal Cyst	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infected Skin Ulcer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infection	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infectious Colitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infectious Pleural Effusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Infective Exacerbation Of Chronic Obstructive Airways Disease	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Influenza	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Intervertebral Discitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Joint Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Kidney Infection	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Klebsiella Sepsis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Labyrinthitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Laryngitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Liver Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lobar Pneumonia	0.18% 16/9067 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Localised Infection	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lower Respiratory Tract Infection	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lower Respiratory Tract Infection Viral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lung Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lung Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lyme Disease	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Lymph Node Tuberculosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Mastoiditis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Mediastinitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Meningitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Meningitis Aseptic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Meningitis Viral	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Myelitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Myringitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Nasopharyngitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Necrotising Fasciitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Oesophageal Candidiasis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Orchitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Osteomyelitis	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Osteomyelitis Chronic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Otitis Media	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Otitis Media Chronic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pancreas Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Parotitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Perineal Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Periodontitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Perirectal Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Peritonitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Peritonitis Bacterial	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Peritonsillar Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Periumbilical Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pharyngitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pilonidal Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumococcal Sepsis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia	2.8% 255/9067 • Number of events 255 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	2.7% 242/9077 • Number of events 242 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Bacterial	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Chlamydial	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Influenzal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Legionella	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Pneumococcal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Pseudomonal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Streptococcal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pneumonia Viral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Post Procedural Infection	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Postoperative Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Postoperative Wound Infection	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Proctitis Infectious	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Prostate Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pseudomembranous Colitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pseudomonas Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Psoas Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pulmonary Sepsis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pulmonary Tuberculosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pyelonephritis	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pyelonephritis Acute	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Pyomyositis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Q Fever	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Rectal Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Renal Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Respiratory Tract Infection	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Respiratory Tract Infection Viral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Rhinitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Rotavirus Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Scrotal Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Sepsis	0.41% 37/9067 • Number of events 37 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.36% 33/9077 • Number of events 33 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Sepsis Syndrome	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Septic Encephalopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Septic Shock	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Serratia Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Shunt Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Sinusitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Skin Infection	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Soft Tissue Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Staphylococcal Abscess	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Staphylococcal Bacteraemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Staphylococcal Infection	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Staphylococcal Sepsis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Sternitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Streptococcal Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Subacute Endocarditis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Subcutaneous Abscess	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Sweat Gland Infection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Tick-Borne Fever	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Tonsillitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Tooth Abscess	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Tracheitis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Tracheobronchitis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Tuberculosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Upper Respiratory Tract Infection	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Urinary Tract Infection	0.85% 77/9067 • Number of events 77 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.87% 79/9077 • Number of events 79 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Urinary Tract Infection Bacterial	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Urosepsis	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.21% 19/9077 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Vestibular Neuronitis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Viral Infection	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Viral Upper Respiratory Tract Infection	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Wound Abscess	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Wound Infection	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Wound Sepsis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Accidental Overdose	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Acetabulum Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Alcohol Poisoning	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Anaemia Postoperative	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Anastomotic Leak	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Anastomotic Stenosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Animal Bite	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Ankle Fracture	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Arterial Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Arthropod Sting	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Bone Contusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Burns Second Degree	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Bursa Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Carbon Monoxide Poisoning	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Chance Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Chemical Poisoning	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Chest Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Clavicle Fracture	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Compression Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Concussion	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Contusion	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Coronary Artery Restenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Craniocerebral Injury	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Electric Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Eye Penetration	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Face Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Facial Bones Fracture	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Fall	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Fat Embolism	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Femur Fracture	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Fibula Fracture	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Foot Fracture	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Forearm Fracture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Foreign Body	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Fracture	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Fractured Ischium	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Fractured Sacrum	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Gastroenteritis Radiation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Gastrointestinal Anastomotic Leak	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Gun Shot Wound	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Hand Fracture	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Head Injury	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Heat Exhaustion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Heat Illness	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Heat Stroke	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Hip Fracture	0.31% 28/9067 • Number of events 28 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.25% 23/9077 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Humerus Fracture	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Incision Site Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Incisional Hernia	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Incisional Hernia, Obstructive	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Inflammation Of Wound	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Injury	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Intentional Overdose	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Joint Dislocation	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Joint Injury	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Kidney Contusion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Kidney Rupture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Laceration	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Ligament Rupture	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Limb Crushing Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Limb Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Lower Limb Fracture	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Meniscus Injury	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Mouth Injury	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Multiple Fractures	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Multiple Injuries	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Muscle Rupture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Muscle Strain	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Near Drowning	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Open Fracture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Overdose	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Pancreatic Leak	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Patella Fracture	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Pelvic Fracture	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Peripheral Nerve Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Periprosthetic Fracture	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Periprosthetic Osteolysis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Pneumothorax Traumatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Poisoning	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Post Concussion Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Post Gastric Surgery Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Post Laminectomy Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Post Procedural Haematuria	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Postmastectomy Lymphoedema Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Postoperative Ileus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Postoperative Thoracic Procedure Complication	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Postpericardiotomy Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Procedural Hypotension	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Procedural Intestinal Perforation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Procedural Pain	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Pubis Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Pulmonary Contusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Radiation Proctitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Radius Fracture	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Renal Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Rib Fracture	0.20% 18/9067 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Road Traffic Accident	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Scapula Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Scar	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Scrotal Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Seroma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Shunt Malfunction	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Silicosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Skeletal Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Skin Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Skull Fracture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Snake Bite	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Soft Tissue Injury	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Spinal Column Injury	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Spinal Cord Injury Cauda Equina	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Spinal Fracture	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Splenic Rupture	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Sternal Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Sternal Injury	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Stoma Site Ulcer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Subcutaneous Haematoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Subdural Haematoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Suture Related Complication	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Synovial Rupture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Tendon Injury	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Tendon Rupture	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Thermal Burn	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Tibia Fracture	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Tracheostomy Malfunction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Transfusion Reaction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Traumatic Fracture	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Traumatic Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Traumatic Haemothorax	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Ulna Fracture	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Upper Limb Fracture	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Urinary Bladder Rupture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Urinary Retention Postoperative	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm Ruptured	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Wound	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Wound Dehiscence	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Wound Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Wound Haemorrhage	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Injury, poisoning and procedural complications Wrist Fracture	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Alanine Aminotransferase Increased	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Anticoagulation Drug Level Below Therapeutic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Creatine Increased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Creatine Phosphokinase Increased	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Creatinine Increased	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Glucose Abnormal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Glucose Increased	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Pressure Increased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Pressure Orthostatic Decreased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Blood Urine Present	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Body Temperature Increased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Clostridium Test Positive	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Colonoscopy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Ejection Fraction Decreased	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Electrocardiogram Qt Prolonged	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Electrocardiogram Repolarisation Abnormality	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Endoscopy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Endoscopy Gastrointestinal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Gastrointestinal Examination	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Haemoglobin Decreased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Heart Rate Decreased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Heart Rate Increased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Heart Rate Irregular	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Hepatic Enzyme Increased	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations International Normalised Ratio Decreased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations International Normalised Ratio Increased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Laboratory Test Abnormal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Liver Function Test Abnormal	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Occult Blood Positive	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Precancerous Cells Present	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Prostatic Specific Antigen Increased	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Psychiatric Evaluation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Total Lung Capacity Decreased	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Transaminases Increased	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Tumour Marker Increased	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Weight Decreased	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Investigations Weight Increased	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Abnormal Loss Of Weight	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Cachexia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Cholesterosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Dehydration	0.37% 34/9067 • Number of events 34 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Diabetes Mellitus	0.24% 22/9067 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.32% 29/9077 • Number of events 29 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Diabetes With Hyperosmolarity	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Diabetic Complication	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Failure To Thrive	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Fluid Overload	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Glucose Tolerance Impaired	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Gout	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hyperammonaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hypercalcaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hyperglycaemia	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hyperkalaemia	0.18% 16/9067 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hyperosmolar State	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hypoglycaemia	0.22% 20/9067 • Number of events 20 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.19% 17/9077 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hypokalaemia	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hyponatraemia	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Hypovolaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Malnutrition	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Obesity	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Overweight	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Tumour Lysis Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Type 1 Diabetes Mellitus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.28% 25/9067 • Number of events 25 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.25% 23/9077 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Arthritis	0.35% 32/9067 • Number of events 32 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.25% 23/9077 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Arthritis Reactive	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Arthropathy	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Back Pain	0.40% 36/9067 • Number of events 36 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.37% 34/9077 • Number of events 34 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Bone Lesion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Bone Pain	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Bursitis	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Chest Wall Cyst	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Chest Wall Mass	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Chondropathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Costochondritis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Diastasis Recti Abdominis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Epiphysitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Extraskeletal Ossification	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Fistula	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Flank Pain	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Foot Deformity	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Fracture Malunion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Fracture Nonunion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Gouty Arthritis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Groin Pain	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Intervertebral Disc Compression	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Intervertebral Disc Displacement	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.31% 28/9067 • Number of events 28 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.39% 35/9077 • Number of events 35 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Joint Effusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Joint Instability	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Joint Swelling	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Knee Deformity	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Limb Discomfort	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Lower Extremity Mass	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Monarthritis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Morphoea	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Muscle Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.37% 34/9067 • Number of events 34 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.23% 21/9077 • Number of events 21 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Myalgia	0.22% 20/9067 • Number of events 20 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Myalgia Intercostal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Myofascial Pain Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Myopathy	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Myositis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Neck Mass	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Neck Pain	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Neuropathic Arthropathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.9% 175/9067 • Number of events 175 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.8% 159/9077 • Number of events 159 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Osteolysis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Pain In Jaw	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Periarthritis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Polymyositis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Psoriatic Arthropathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Rheumatic Fever	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Rib Deformity	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.23% 21/9067 • Number of events 21 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Scleroderma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Soft Tissue Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.24% 22/9067 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.30% 27/9077 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Spinal Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Spinal Pain	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Spondylitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Synovial Cyst	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Synovial Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Synovitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Systemic Lupus Erythematosus	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Tendon Disorder	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Tendonitis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Upper Extremity Mass	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Vertebral Foraminal Stenosis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic Neuroma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Leukaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Monocytic Leukaemia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Gastric	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of Colon	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenolymphoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma Benign	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Adenoma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Gland Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Neoplasm	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal Squamous Cell Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical Fibroxanthoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma Stage I	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Small Lymphocytic Lymphoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.5% 140/9067 • Number of events 140 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.7% 157/9077 • Number of events 157 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Anorectal Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Bone Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Breast Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Duodenal Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Ear Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Lung Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Bladder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Conjunctiva	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Prostate	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Skin	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Thyroid Gland	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Pancreatic Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Salivary Gland Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Small Intestinal Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.35% 32/9067 • Number of events 32 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.45% 41/9077 • Number of events 41 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Stage 0, With Cancer In Situ	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.19% 17/9067 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.25% 23/9077 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Papilloma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma Recurrent	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma Stage Ii	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma Stage Iii	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Cancer Metastatic	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Giant Cell Tumour	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Neoplasm	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Sarcoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Cancer Metastatic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.35% 32/9067 • Number of events 32 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer In Situ	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Neoplasm	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial Carcinoma	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioloalveolar Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's Lymphoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid Tumour	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid Tumour Pulmonary	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma In Situ	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac Valve Fibroelastoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central Nervous System Lymphoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma Stage 0	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondroma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chondrosarcoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Leukaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia Stage 1	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myeloid Leukaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myelomonocytic Leukaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear Cell Renal Cell Carcinoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	0.25% 23/9067 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.32% 29/9077 • Number of events 29 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.35% 32/9067 • Number of events 32 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.31% 28/9077 • Number of events 28 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Recurrent	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Stage Iii	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Stage Iv	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Neoplasm	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Adenocarcinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Metastatic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cranial Nerve Neoplasm Benign	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic Naevus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endocrine Neoplasm Malignant	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Adenocarcinoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enteropathy-Associated T-Cell Lymphoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential Thrombocythaemia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extradural Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extramammary Paget's Disease	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Eye Naevus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian Tube Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Adenocarcinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Cancer	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Cancer Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Carcinoma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Stromal Tumour	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Tract Adenoma	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.22% 20/9077 • Number of events 20 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma Of Bone	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma Of Liver	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma Of Spleen	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy Cell Leukaemia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Adenoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer Metastatic	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatobiliary Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Huerthle Cell Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia Benign Monoclonal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Immunoblastic Lymphoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory Carcinoma Of The Breast	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory Pseudotumour	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Insulinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal Adenocarcinoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Papillary Mucinous Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Papillary-Mucinous Carcinoma Of Pancreas	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Proliferative Breast Lesion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular Melanoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Lobular Breast Carcinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Cell Lung Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Cell Lung Cancer Stage Iii	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Intestine Benign Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Squamous Cell Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma Metastatic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma Recurrent	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo Maligna	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip And/Or Oral Cavity Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Neoplasm Malignant Stage Unspecified	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Squamous Cell Carcinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lobular Breast Carcinoma In Situ	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage 0	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage I	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage Iv	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.72% 65/9067 • Number of events 65 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.73% 66/9077 • Number of events 66 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic Leukaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Ascites	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.31% 28/9067 • Number of events 28 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.29% 26/9077 • Number of events 26 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma In Situ	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma Stage I	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Of Ampulla Of Vater	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Of Eyelid	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Of Pleura	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Of Unknown Primary Site	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Urinary Tract Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle Cell Lymphoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle Cell Lymphoma Stage Iii	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary Thyroid Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic Naevus	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma Benign	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesenteric Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma Malignant	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Adrenals	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Bone	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Central Nervous System	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Gastrointestinal Tract	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Liver	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lung	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lymph Nodes	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Pancreas	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Pelvis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Peritoneum	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To The Mediastinum	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Carcinoid Tumour	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Carcinoma Of The Bladder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Choriocarcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Gastric Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Lymphoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Malignant Melanoma	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Renal Cell Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Squamous Cell Carcinoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal Gammopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mucoepidermoid Carcinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis Fungoides	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mycosis Fungoides Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloid Leukaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal Sinus Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Natural Killer-Cell Leukaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Prostate	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Skin	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma Metastatic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibroma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma Recurrent	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Secretory Adenoma Of Pituitary	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Metastatic	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Stage Iiia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma Recurrent	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Squamous Cell Carcinoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oligodendroglioma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral Neoplasm Benign	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteochondroma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Epithelial Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.19% 17/9067 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.22% 20/9077 • Number of events 20 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Stage Iv	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Neoplasm	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraproteinaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid Tumour Benign	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pelvic Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Recurrent	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic Adenoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic Liposarcoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural Mesothelioma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia Vera	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prolactin-Producing Pituitary Tumour	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.4% 123/9067 • Number of events 123 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.3% 117/9077 • Number of events 117 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Recurrent	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Stage Ii	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic Adenoma	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Neoplasm	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid Cancer	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.21% 19/9077 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Oncocytoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Adenoma	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcomatoid Mesothelioma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic Keratosis	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.20% 18/9067 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Carcinoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Intestine Carcinoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spindle Cell Sarcoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.93% 84/9067 • Number of events 84 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.0% 91/9077 • Number of events 91 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Head And Neck	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Lung	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.14% 13/9067 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Oral Cavity	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Tongue	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sweat Gland Tumour	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-Cell Lymphoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Throat Cancer	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma Malignant	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma Malignant Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Adenoma	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer Metastatic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Neoplasm	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Cancer Metastatic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Neoplasm Malignant Stage Unspecified	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tracheal Cancer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tracheal Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.17% 15/9067 • Number of events 15 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteral Neoplasm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric Cancer	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric Cancer Recurrent	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary Bladder Adenoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary Bladder Sarcoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary Tract Neoplasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Amnesia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Amyotrophic Lateral Sclerosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Arachnoid Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Ataxia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Autonomic Nervous System Imbalance	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Balance Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Brain Injury	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Carotid Artery Aneurysm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Carotid Artery Occlusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Carotid Artery Stenosis	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Carotid Sinus Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Carpal Tunnel Syndrome	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Central Nervous System Lesion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cerebrospinal Fluid Leakage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cerebrovascular Accident	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cervical Cord Compression	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cervical Myelopathy	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cervical Radiculopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cervicobrachial Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Cognitive Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Complex Partial Seizures	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Complicated Migraine	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Convulsion	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Dementia	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Dementia Alzheimer's Type	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Demyelination	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Diabetic Coma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Diabetic Hyperglycaemic Coma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Diabetic Neuropathy	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Dizziness	0.33% 30/9067 • Number of events 30 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.33% 30/9077 • Number of events 30 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Encephalopathy	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Epilepsy	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Extrapyramidal Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Facial Paresis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Grand Mal Convulsion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Guillain-Barre Syndrome	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Headache	0.12% 11/9067 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.14% 13/9077 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hemiparesis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hepatic Encephalopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hydrocephalus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hypertensive Encephalopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hypoaesthesia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hypotonia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Intercostal Neuralgia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Intracranial Aneurysm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Lethargy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Leukoencephalopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Loss Of Consciousness	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Lumbar Radiculopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Metabolic Encephalopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Migraine	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Migraine With Aura	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Motor Neurone Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Multiple Sclerosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Muscle Spasticity	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Myasthenia Gravis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Myelopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Nerve Compression	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Nervous System Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Neuralgia	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Neurological Symptom	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Neuropathy Peripheral	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Normal Pressure Hydrocephalus	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Occipital Neuralgia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Paraesthesia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Paralysis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Paraparesis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Paraplegia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Parkinson's Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Parkinsonism	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Partial Seizures	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Perineurial Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Peripheral Paralysis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Pneumocephalus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Polyneuropathy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Polyneuropathy Chronic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Post Polio Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Presyncope	0.18% 16/9067 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.22% 20/9077 • Number of events 20 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Radial Nerve Palsy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Radicular Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Radiculopathy	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Sciatica	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Somnolence	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Spinal Cord Compression	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Spinal Cord Ischaemia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Spondylitic Myelopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Status Epilepticus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Syncope	1.2% 107/9067 • Number of events 107 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.1% 96/9077 • Number of events 96 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Tarsal Tunnel Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Tension Headache	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Toxic Encephalopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Transient Global Amnesia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Tremor	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Trigeminal Neuralgia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Unresponsive To Stimuli	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Vascular Dementia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Vertebral Artery Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Vertebrobasilar Insufficiency	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Viith Nerve Paralysis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Vith Nerve Paralysis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Vith Nerve Paresis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Abnormal Behaviour	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Acute Psychosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Alcohol Abuse	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Alcoholism	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Anxiety	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Anxiety Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Bipolar Disorder	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Bipolar I Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Bipolar Ii Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Burnout Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Completed Suicide	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Confusional State	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Conversion Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Delirium	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Delirium Tremens	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Depression	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.19% 17/9077 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Disorientation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Generalised Anxiety Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Hallucination	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Hypomania	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Insomnia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Major Depression	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Mental Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Mental Disorder Due To A General Medical Condition	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Mental Status Changes	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Neurosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Panic Attack	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Paranoia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Post-Traumatic Stress Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Psychotic Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Schizophrenia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Schizophrenia, Paranoid Type	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Sleep Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Somatisation Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Somatoform Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Stress	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Suicidal Ideation	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Suicide Attempt	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Psychiatric disorders Withdrawal Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Acute Prerenal Failure	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Azotaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Diverticulum	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Mass	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Neck Obstruction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Neck Sclerosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Obstruction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Perforation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Prolapse	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Spasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Bladder Tamponade	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Calculus Bladder	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Calculus Ureteric	0.18% 16/9067 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.12% 11/9077 • Number of events 11 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Calculus Urethral	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Calculus Urinary	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Crush Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Cystitis Haemorrhagic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Cystitis Noninfective	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Dysuria	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Glomerulonephritis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Haematuria	0.30% 27/9067 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.22% 20/9077 • Number of events 20 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Hydronephrosis	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Hypertonic Bladder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Hypotonic Urinary Bladder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Lower Urinary Tract Symptoms	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Nephrolithiasis	0.34% 31/9067 • Number of events 31 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.39% 35/9077 • Number of events 35 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Nephropathy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Nephrosclerosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Nephrotic Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Obstructive Uropathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Aneurysm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Artery Stenosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Colic	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Cyst	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Cyst Ruptured	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Embolism	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Failure	0.42% 38/9067 • Number of events 38 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.32% 29/9077 • Number of events 29 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Failure Acute	0.56% 51/9067 • Number of events 51 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.67% 61/9077 • Number of events 61 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Failure Chronic	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Hypertension	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Impairment	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Infarct	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Injury	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Mass	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Renal Tubular Necrosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Stress Urinary Incontinence	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Tubulointerstitial Nephritis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Ureteric Dilatation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Ureteric Obstruction	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Ureteric Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urethral Caruncle	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urethral Dilatation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urethral Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urethral Stenosis	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.11% 10/9077 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urge Incontinence	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urinary Bladder Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urinary Bladder Polyp	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urinary Incontinence	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urinary Retention	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.30% 27/9077 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urinary Tract Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Renal and urinary disorders Urinary Tract Obstruction	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.79% 72/9067 • Number of events 72 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.79% 72/9077 • Number of events 72 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Breast Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Breast Mass	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Cervical Dysplasia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Cervical Polyp	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Cystocele	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Endometrial Hyperplasia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Endometrial Hypertrophy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Female Genital Tract Fistula	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Fibrocystic Breast Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Gynaecomastia	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Menorrhagia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Ovarian Cyst	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Ovarian Mass	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Pelvic Haematoma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Pelvic Prolapse	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Penile Vein Thrombosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Penis Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Peyronie's Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatic Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatic Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatic Dysplasia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatic Obstruction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatism	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatitis	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Prostatomegaly	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Rectoprostatic Fistula	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Scrotal Haematocoele	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Spermatocele	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Uterine Inflammation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Uterine Polyp	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Uterine Prolapse	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Uterovaginal Prolapse	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Vaginal Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Vaginal Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Vaginal Hyperplasia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Reproductive system and breast disorders Vaginal Prolapse	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.20% 18/9067 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.13% 12/9077 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Asthma	0.14% 13/9067 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.19% 17/9077 • Number of events 17 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchial Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchial Hyperreactivity	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchial Obstruction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.2% 109/9067 • Number of events 109 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	1.2% 105/9077 • Number of events 105 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Chronic Respiratory Disease	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Cough	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.52% 47/9067 • Number of events 47 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.62% 56/9077 • Number of events 56 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea Paroxysmal Nocturnal	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.25% 23/9067 • Number of events 23 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Idiopathic Pulmonary Fibrosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Laryngeal Cyst	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Laryngeal Oedema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Laryngeal Polyp	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Laryngeal Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Laryngeal Ulceration	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Lung Hernia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Nasal Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Nasal Septum Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Nasal Turbinate Hypertrophy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Obstructive Airways Disorder	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Organising Pneumonia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pickwickian Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.26% 24/9067 • Number of events 24 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.26% 24/9077 • Number of events 24 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pleural Fibrosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.15% 14/9067 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax Spontaneous	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Arterial Hypertension	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.51% 46/9067 • Number of events 46 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.40% 36/9077 • Number of events 36 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Granuloma	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.35% 32/9067 • Number of events 32 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Restrictive Pulmonary Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Status Asthmaticus	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Tracheal Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Inflammation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Vocal Cord Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Vocal Cord Inflammation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Vocal Cord Leukoplakia	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Vocal Cord Polyp	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.20% 18/9077 • Number of events 18 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Angioedema	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Campbell De Morgan Spots	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Dermal Cyst	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Dermatomyositis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Diabetic Foot	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Diabetic Ulcer	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Drug Eruption	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Ecchymosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Eczema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Excessive Granulation Tissue	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Granuloma Skin	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Hypersensitivity Vasculitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Lichen Planus	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Lichenoid Keratosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Macule	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Palmoplantar Keratoderma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Pemphigoid	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Pityriasis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Precancerous Skin Lesion	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Punctate Keratosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Rash	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Rash Generalised	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Rash Papular	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Skin Burning Sensation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Skin Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Skin Lesion	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Skin Mass	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Skin Ulcer	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Solar Lentigo	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Swelling Face	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Toxic Skin Eruption	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Skin and subcutaneous tissue disorders Urticaria	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Social circumstances Cardiac Assistance Device User	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Appendicectomy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Arthrodesis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Bladder Catheterisation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Cardiac Pacemaker Replacement	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Cardiac Rehabilitation Therapy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Cataract Operation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Cholecystectomy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Colectomy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Colostomy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Fascia Release	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Finger Amputation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Gastrectomy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Gastric Bypass	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Gastrointestinal Surgery	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Hernia Repair	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Hip Arthroplasty	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Hip Surgery	0.09% 8/9067 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.10% 9/9077 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Hospitalisation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Ileostomy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Immunoglobulin Therapy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Implantable Defibrillator Insertion	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Incisional Hernia Repair	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Intraocular Lens Implant	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Joint Arthroplasty	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Knee Arthroplasty	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Knee Operation	0.14% 13/9067 • Number of events 13 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.09% 8/9077 • Number of events 8 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Mammoplasty	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Mitral Valve Repair	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Nasal Polypectomy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Nasal Septal Operation	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Penile Prosthesis Insertion	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Percutaneous Coronary Intervention	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Preoperative Care	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Prophylaxis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Prostatectomy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Rehabilitation Therapy	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Rotator Cuff Repair	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Shoulder Arthroplasty	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Shoulder Operation	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Spinal Decompression	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Surgery	0.08% 7/9067 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Suture Removal	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Thyroidectomy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Tooth Extraction	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Transurethral Bladder Resection	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Transurethral Prostatectomy	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Turbinectomy	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Varicose Vein Operation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Surgical and medical procedures Vertebroplasty	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Accelerated Hypertension	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aneurysm	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Angiodysplasia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Angiopathy	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Aneurysm	0.32% 29/9067 • Number of events 29 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.44% 40/9077 • Number of events 40 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Aneurysm Rupture	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Dilatation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Disorder	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Dissection	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Rupture	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Aortic Stenosis	0.10% 9/9067 • Number of events 9 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Arterial Haemorrhage	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Arterial Occlusive Disease	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Arterial Thrombosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Arteriosclerosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Arteriovenous Fistula	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Behcet's Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Blood Pressure Fluctuation	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Blood Pressure Inadequately Controlled	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Deep Vein Thrombosis	0.21% 19/9067 • Number of events 19 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.36% 33/9077 • Number of events 33 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Embolism	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Essential Hypertension	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Extremity Necrosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Femoral Artery Aneurysm	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Femoral Artery Occlusion	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Granulomatosis With Polyangiitis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Haematoma	0.13% 12/9067 • Number of events 12 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Haemorrhage	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hot Flush	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hypertension	0.28% 25/9067 • Number of events 25 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.30% 27/9077 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hypertensive Crisis	0.23% 21/9067 • Number of events 21 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.24% 22/9077 • Number of events 22 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hypertensive Emergency	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hypotension	0.30% 27/9067 • Number of events 27 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.18% 16/9077 • Number of events 16 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hypovolaemic Shock	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Iliac Artery Occlusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Intermittent Claudication	0.07% 6/9067 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.07% 6/9077 • Number of events 6 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Intra-Abdominal Haematoma	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Ischaemia	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Jugular Vein Thrombosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Leriche Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Lymphatic Fistula	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Lymphocele	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Lymphoedema	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Malignant Hypertension	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Necrosis Ischaemic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Neurogenic Shock	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Orthostatic Hypotension	0.11% 10/9067 • Number of events 10 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.15% 14/9077 • Number of events 14 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Arterial Occlusive Disease	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Artery Aneurysm	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Artery Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Artery Thrombosis	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Embolism	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.08% 7/9077 • Number of events 7 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Ischaemia	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Peripheral Vascular Disorder	0.06% 5/9067 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.04% 4/9077 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Phlebitis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Post Thrombotic Syndrome	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Shock Haemorrhagic	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Subclavian Artery Stenosis	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Superior Vena Cava Occlusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Superior Vena Cava Syndrome	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Temporal Arteritis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Thrombophlebitis	0.03% 3/9067 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Thrombophlebitis Superficial	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Thrombosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Varicose Ulceration	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Varicose Vein	0.04% 4/9067 • Number of events 4 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.06% 5/9077 • Number of events 5 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Vascular Occlusion	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Vasculitis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Vasculitis Necrotising	0.00% 0/9067 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.01% 1/9077 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Venous Insufficiency	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.03% 3/9077 • Number of events 3 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Venous Stenosis	0.01% 1/9067 • Number of events 1 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.00% 0/9077 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Venous Thrombosis Limb	0.02% 2/9067 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	0.02% 2/9077 • Number of events 2 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.

Other adverse events

Other adverse events
Measure	Ezetimide/Simvastatin n=9067 participants at risk One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.	Simvastatin n=9077 participants at risk One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
Gastrointestinal disorders Diarrhoea	6.0% 540/9067 • Number of events 540 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	6.1% 552/9077 • Number of events 552 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Chest Pain	7.7% 694/9067 • Number of events 694 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	8.1% 731/9077 • Number of events 731 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Fatigue	7.9% 720/9067 • Number of events 720 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	8.3% 756/9077 • Number of events 756 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Non-Cardiac Chest Pain	6.1% 554/9067 • Number of events 554 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	6.0% 543/9077 • Number of events 543 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
General disorders Oedema Peripheral	5.7% 520/9067 • Number of events 520 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	6.1% 551/9077 • Number of events 551 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Bronchitis	5.3% 477/9067 • Number of events 477 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	5.0% 450/9077 • Number of events 450 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Influenza	5.1% 461/9067 • Number of events 461 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	5.3% 483/9077 • Number of events 483 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Infections and infestations Nasopharyngitis	6.8% 618/9067 • Number of events 618 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	6.4% 577/9077 • Number of events 577 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Arthralgia	11.0% 1001/9067 • Number of events 1001 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	10.1% 914/9077 • Number of events 914 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Back Pain	9.6% 866/9067 • Number of events 866 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	9.1% 825/9077 • Number of events 825 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Muscle Spasms	6.8% 616/9067 • Number of events 616 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	6.3% 576/9077 • Number of events 576 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	6.4% 581/9067 • Number of events 581 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	5.9% 535/9077 • Number of events 535 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Myalgia	10.5% 954/9067 • Number of events 954 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	10.0% 908/9077 • Number of events 908 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Musculoskeletal and connective tissue disorders Pain In Extremity	10.5% 955/9067 • Number of events 955 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	9.9% 899/9077 • Number of events 899 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Dizziness	9.7% 875/9067 • Number of events 875 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	10.0% 909/9077 • Number of events 909 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Nervous system disorders Headache	5.2% 467/9067 • Number of events 467 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	5.7% 520/9077 • Number of events 520 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 702/9067 • Number of events 702 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	8.2% 740/9077 • Number of events 740 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 787/9067 • Number of events 787 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	9.0% 815/9077 • Number of events 815 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.
Vascular disorders Hypertension	6.4% 580/9067 • Number of events 580 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.	7.1% 642/9077 • Number of events 642 • up to 30 days after last dose of study drug (Up to approximately 9 years maximum) Safety Population included all participants randomly assigned to a treatment arm.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All draft publications (eg, original manuscripts and abstracts of data and information relating to the IMPROVE-IT clinical study) shall be submitted to the Publication Committee at least 45 days prior to submission to a journal or public presentation.
Publication restrictions are in place

Restriction type: OTHER