Trial Outcomes & Findings for Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries (NCT NCT03080935)

NCT ID: NCT03080935

Last Updated: 2024-05-29

Results Overview

All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1600 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2024-05-29

Participant Flow

This was an open-label extension of study 20110118 (NCT01764633). Eligible participants were enrolled after the completion of the 20110118 study. 1600 participants were enrolled at 86 centers in Belgium, Germany, Denmark, France, Italy, Portugal, and Sweden from 13 March 2017 to 04 March 2022.

1600 participants were enrolled and 1599 of those participants received study drug.

Participant milestones

Measure	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.
Overall Study STARTED	745	855
Overall Study COMPLETED	695	786
Overall Study NOT COMPLETED	50	69

Reasons for withdrawal

Measure	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.
Overall Study Death	34	50
Overall Study Lost to Follow-up	5	4
Overall Study Withdrawal by Subject	11	15

Baseline Characteristics

Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

Baseline characteristics by cohort

Measure	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=745 Participants Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=854 Participants Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.	Total n=1599 Participants Total of all reporting groups
Sex: Female, Male Female	138 Participants n=5 Participants	151 Participants n=7 Participants	289 Participants n=5 Participants
Sex: Female, Male Male	607 Participants n=5 Participants	703 Participants n=7 Participants	1310 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	728 Participants n=5 Participants	830 Participants n=7 Participants	1558 Participants n=5 Participants
Age, Continuous	62.7 Years STANDARD_DEVIATION 9.1 • n=5 Participants	62.6 Years STANDARD_DEVIATION 8.9 • n=7 Participants	62.6 Years STANDARD_DEVIATION 9.0 • n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	706 Participants n=5 Participants	797 Participants n=7 Participants	1503 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	38 Participants n=5 Participants	53 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.

All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.

Outcome measures

Measure	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=854 Participants Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=745 Participants Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.
Number of Participants Who Experienced an Adverse Event	810 Participants	686 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

Population: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.

Outcome measures

Measure	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=854 Participants Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=745 Participants Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 260	-64.72 Percent Change Standard Deviation 29.50	-66.45 Percent Change Standard Deviation 29.84
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 12	-67.24 Percent Change Standard Deviation 25.23	-66.32 Percent Change Standard Deviation 26.88
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 24	-66.47 Percent Change Standard Deviation 28.11	-66.48 Percent Change Standard Deviation 27.52
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 48	-63.45 Percent Change Standard Deviation 26.03	-62.61 Percent Change Standard Deviation 26.60
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 72	-65.33 Percent Change Standard Deviation 28.42	-65.58 Percent Change Standard Deviation 28.13
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 96	-63.43 Percent Change Standard Deviation 28.80	-64.58 Percent Change Standard Deviation 27.01
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 120	-63.10 Percent Change Standard Deviation 29.56	-64.26 Percent Change Standard Deviation 28.31
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 144	-65.13 Percent Change Standard Deviation 31.96	-66.79 Percent Change Standard Deviation 29.22
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 168	-63.55 Percent Change Standard Deviation 29.60	-65.28 Percent Change Standard Deviation 27.55
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 192	-62.46 Percent Change Standard Deviation 26.39	-65.02 Percent Change Standard Deviation 27.93
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit Week 216	-62.46 Percent Change Standard Deviation 28.32	-64.92 Percent Change Standard Deviation 27.93

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260

Population: OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.

Outcome measures

Measure	Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=854 Participants Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.	Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study n=745 Participants Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference.
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Baseline in parent study	0 Percentage of Participants Interval 0.0 to 0.4	0 Percentage of Participants Interval 0.0 to 0.5
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 12	72.5 Percentage of Participants Interval 69.4 to 75.4	72.8 Percentage of Participants Interval 69.4 to 75.9
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 24	73.4 Percentage of Participants Interval 70.3 to 76.2	72.9 Percentage of Participants Interval 69.5 to 76.0
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 48	68.0 Percentage of Participants Interval 64.8 to 71.1	66.5 Percentage of Participants Interval 63.0 to 69.9
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 72	72.3 Percentage of Participants Interval 69.1 to 75.2	73.2 Percentage of Participants Interval 69.8 to 76.3
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 96	69.2 Percentage of Participants Interval 65.9 to 72.3	71.1 Percentage of Participants Interval 67.6 to 74.3
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 120	68.6 Percentage of Participants Interval 65.3 to 71.8	70.9 Percentage of Participants Interval 67.5 to 74.2
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 144	72.2 Percentage of Participants Interval 68.5 to 75.7	75.3 Percentage of Participants Interval 71.2 to 78.9
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 168	69.3 Percentage of Participants Interval 65.9 to 72.5	72.3 Percentage of Participants Interval 68.8 to 75.6
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 192	66.3 Percentage of Participants Interval 62.8 to 69.7	71.6 Percentage of Participants Interval 67.9 to 74.9
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 216	67.3 Percentage of Participants Interval 63.9 to 70.6	72.1 Percentage of Participants Interval 68.6 to 75.4
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL Week 260	68.8 Percentage of Participants Interval 64.2 to 73.0	76.1 Percentage of Participants Interval 71.6 to 80.2

Adverse Events

Placebo in Parent Study

Serious events: 323 serious events

Other events: 451 other events

Deaths: 35 deaths

Evolocumab in Parent Study

Serious events: 410 serious events

Other events: 528 other events

Deaths: 51 deaths

Serious adverse events

Measure	Placebo in Parent Study n=745 participants at risk Participants with Placebo in Parent Study	Evolocumab in Parent Study n=854 participants at risk Participants with Evolocumab in Parent Study
Skin and subcutaneous tissue disorders Pruritus	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin necrosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Eating disorder	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Ejection fraction decreased	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations International normalised ratio abnormal	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Oxygen saturation abnormal	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations SARS-CoV-2 antibody test positive	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Transvalvular pressure gradient increased	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Troponin increased	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dental caries	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Electrolyte imbalance	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Microcytic anaemia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Necrotic lymphadenopathy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute coronary syndrome	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.82% 7/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	2.4% 18/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.8% 15/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	3.5% 26/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.8% 24/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Angina unstable	2.0% 15/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.5% 13/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve calcification	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve incompetence	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve stenosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Arrhythmia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Arteriosclerosis coronary artery	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	2.0% 15/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.6% 22/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial flutter	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block complete	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block second degree	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Bradycardia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Bundle branch block left	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	2.3% 17/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.2% 27/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure acute	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.70% 6/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	0.81% 6/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac valve disease	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiogenic shock	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiorenal syndrome	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Chronic coronary syndrome	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.81% 6/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.2% 10/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery occlusion	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery stenosis	0.67% 5/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.3% 11/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery thrombosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary ostial stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Dressler's syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Extrasystoles	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Left ventricular dysfunction	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Left ventricular failure	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Left ventricular hypertrophy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Low cardiac output syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Mitral valve incompetence	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Mitral valve stenosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	0.81% 6/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 9/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	0.94% 7/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinoatrial block	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus node dysfunction	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular extrasystoles	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular fibrillation	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	1.1% 8/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Atrial septal defect	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Pyloric stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Von Hippel-Lindau disease	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Meniere's disease	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo positional	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Adrenal haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Hypercalcaemia of malignancy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Blepharitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Blindness	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Corneal oedema	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Diplopia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Glaucoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Keratopathy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Lens dislocation	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Visual impairment	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vascular stent thrombosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis microscopic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Enlarged uvula	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric cyst	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric polyps	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematemesis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Hiatus hernia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal ischaemia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal polyp	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine perforation	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Lumbar hernia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Melaena	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oedematous pancreatitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophagitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Peritoneal haematoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal polyp	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Umbilical hernia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Asthenia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest discomfort	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest pain	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.82% 7/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Death	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Disease progression	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fibrosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders General physical health deterioration	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Impaired healing	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Incarcerated hernia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Inflammation	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Malaise	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Multiple organ dysfunction syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Necrosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.2% 10/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Stent-graft endoleak	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Sudden cardiac death	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Sudden death	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Systemic inflammatory response syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Unevaluable event	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vascular stent occlusion	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vascular stent stenosis	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Biliary colic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Biliary polyp	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis acute	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.1% 9/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis obstructive	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholestasis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Liver disorder	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Anti-neutrophil cytoplasmic antibody positive vasculitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Abdominal abscess	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Abscess jaw	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Appendicitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Arthritis bacterial	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacterial infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19	0.81% 6/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Campylobacter gastroenteritis	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cholecystitis infective	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cystitis	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Dermo-hypodermitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diverticulitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diverticulitis intestinal haemorrhagic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Empyema	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Epididymitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Erysipelas	0.94% 7/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Escherichia urinary tract infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis bacterial	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Groin abscess	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Hepatitis A	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes zoster cutaneous disseminated	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infection	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infectious pleural effusion	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Influenza	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Intervertebral discitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Klebsiella infection	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Liver abscess	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Localised infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lymphangitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Mediastinal abscess	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Meningitis streptococcal	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Oral infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Parainfluenzae virus infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Peritonitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	2.0% 15/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.2% 19/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia aspiration	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia bacterial	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia influenzal	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia mycoplasmal	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia pneumococcal	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia staphylococcal	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia viral	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Post procedural infection	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Postoperative wound infection	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Prostatitis Escherichia coli	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pulmonary tuberculosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pyelonephritis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Septic embolus	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Septic shock	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal bacteraemia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal infection	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Stomatococcal infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tracheobronchitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection bacterial	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urosepsis	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Vascular device infection	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Accidental overdose	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Alcohol poisoning	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Chest injury	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Comminuted fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Concussion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Coronary artery restenosis	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Electric injury	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Facial bones fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.70% 6/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fibula fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fractured sacrum	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Haematuria traumatic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hand fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Humerus fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hyphaema	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint dislocation	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint dislocation postoperative	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Medical device monitoring error	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Multiple injuries	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Muscle contusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Patella fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural swelling	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pneumothorax	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Restenosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Scratch	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Seroma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin injury	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin wound	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skull fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Splinter	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tendon rupture	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tibia fracture	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic arthrosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular anastomosis aneurysm	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular graft occlusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular graft stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound complication	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound haemorrhage	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood pressure orthostatic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations C-reactive protein increased	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Cardiac function test abnormal	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Echocardiogram abnormal	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Overweight	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Steroid diabetes	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Exostosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Inclusion body myositis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.70% 6/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 8/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.8% 15/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.94% 7/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Tendon pain	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma metastatic	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign anorectal neoplasm	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage III	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage I	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer male	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer fatigue	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chromophobe renal cell carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage I	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enchondromatosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna stage I	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal neoplasm benign	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancoast's tumour	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma malignant	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural neoplasm	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.81% 6/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.82% 7/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Richter's syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin angiosarcoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma stage IV	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Amputation stump pain	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carotid arteriosclerosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carotid artery stenosis	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral artery embolism	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral atrophy	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral haemorrhage	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral thrombosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.70% 6/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Coma	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dementia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dementia with Lewy bodies	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dysaesthesia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Embolic stroke	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Epilepsy	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Essential tremor	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hemiplegia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hydrocephalus	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Ischaemic stroke	1.1% 8/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.6% 14/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Memory impairment	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Nerve compression	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Peripheral nerve lesion	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Piriformis syndrome	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Post-traumatic headache	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Sciatic nerve neuropathy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Sciatica	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Seizure	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Syncope	1.3% 10/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.2% 10/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Transient global amnesia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	1.2% 9/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders VIth nerve paralysis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device dislocation	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device material issue	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device occlusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device physical property issue	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device power source issue	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Alcohol abuse	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Alcoholism	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Depression	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Hallucination	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Hallucination, auditory	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Psychiatric decompensation	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Suicide attempt	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.81% 6/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.94% 8/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Calculus bladder	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Calculus urethral	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Calculus urinary	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Cystitis noninfective	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Micturition disorder	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nephropathy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Paroxysmal nocturnal haemoglobinuria	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Ureteric stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Ureterolithiasis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urethral obstruction	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urethral stenosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary bladder polyp	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary retention	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Genital prolapse	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Gynaecomastia	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatomegaly	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.94% 7/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hypertrichosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ischaemic skin ulcer	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Prurigo	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Coronary revascularisation	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Ileectomy	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Implantable defibrillator insertion	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Knee arthroplasty	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Mitral valve repair	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Skin neoplasm excision	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aneurysm	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic aneurysm	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic stenosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arterial stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arteriosclerosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Extremity necrosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Femoral artery aneurysm	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Haematoma	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Haemorrhage	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertensive crisis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Iliac artery occlusion	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Iliac artery stenosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.35% 3/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Intermittent claudication	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Ischaemic limb pain	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Lymphocele	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral arterial occlusive disease	1.6% 12/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.4% 12/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral artery aneurysm	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral artery occlusion	0.27% 2/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.23% 2/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral artery stenosis	0.54% 4/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral ischaemia	0.40% 3/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.47% 4/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral vascular disorder	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.59% 5/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral vein stenosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Subclavian vein thrombosis	0.13% 1/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Thrombosis	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Vascular pain	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Venous thrombosis limb	0.00% 0/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 1/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Measure	Placebo in Parent Study n=745 participants at risk Participants with Placebo in Parent Study	Evolocumab in Parent Study n=854 participants at risk Participants with Evolocumab in Parent Study
Cardiac disorders Atrial fibrillation	5.0% 37/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 49/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Cataract	5.6% 42/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.7% 32/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest pain	5.4% 40/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.4% 29/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	4.3% 32/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 43/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Influenza	5.0% 37/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.2% 53/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	10.1% 75/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	13.0% 111/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	5.6% 42/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.8% 41/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	8.1% 60/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.7% 57/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	8.2% 61/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.8% 75/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	6.7% 50/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.2% 70/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	7.4% 55/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.5% 47/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 24/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.9% 50/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	4.4% 33/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 43/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 39/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.7% 40/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	17.7% 132/745 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	17.6% 150/854 • Up to 5 years All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER