Trial Outcomes & Findings for Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study (NCT NCT02441218)

NCT ID: NCT02441218

Last Updated: 2020-01-03

Results Overview

Number of patients having experienced the Primary Composite Endpoint.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6505 participants
• Primary outcome timeframe: All over the study (up to 42 months).
• Results posted on: 2020-01-03

Participant Flow

The target population was adult patients with stable, moderate to severe chronic heart failure (CHF) and left ventricular systolic dysfunction, with optimal and unchanged CHF medications and dosages for ≥ 4 weeks.

Following a run-in period of two weeks during which no study treatment was dispensed, the participants were randomised to receive ivabradine or placebo in addition to their usual cardiovascular treatment in double-blind treatment period.

Participant milestones

Measure	Ivabradine Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Overall Study STARTED	3241	3264
Overall Study COMPLETED	2663	2652
Overall Study NOT COMPLETED	578	612

Reasons for withdrawal

Measure	Ivabradine Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Overall Study Death	503	553
Overall Study Withdrawal by Subject	73	58
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study

Baseline characteristics by cohort

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Total n=6505 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 11.2 • n=5 Participants	60.1 years STANDARD_DEVIATION 11.5 • n=7 Participants	60.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	779 Participants n=5 Participants	756 Participants n=7 Participants	1535 Participants n=5 Participants
Sex: Female, Male Male	2462 Participants n=5 Participants	2508 Participants n=7 Participants	4970 Participants n=5 Participants
Beta-blocker intake at randomization Yes	2897 participants n=5 Participants	2923 participants n=7 Participants	5820 participants n=5 Participants
Beta-blocker intake at randomization No	344 participants n=5 Participants	341 participants n=7 Participants	685 participants n=5 Participants

PRIMARY outcome

Timeframe: All over the study (up to 42 months).

Number of patients having experienced the Primary Composite Endpoint.

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.	793 participants	937 participants

SECONDARY outcome

Timeframe: From the date of randomization until the date of death, up to 42 months

Component of the primary composite endpoint

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Cardiovascular Death	449 participants	491 participants

SECONDARY outcome

Timeframe: From the date of randomization to the date of first documented hospitalisation, up to 42 months

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Hospitalisation for Worsening Heart Failure	514 participants	672 participants

SECONDARY outcome

Timeframe: From the date of randomisation to death, up to 42 months.

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
All-cause Mortality	503 participants	552 participants

SECONDARY outcome

Timeframe: From the date of randomisation to death, up to 42 months.

Component of cardiovascular death

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Death From Heart Failure	113 participants	151 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of first documented hospitalisation, up to 42 months

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Hospitalisation for Any Cause	1231 participants	1356 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the first documented hospitalisation, up to 42 months

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Hospitalisation for Cardiovascular Reason	977 participants	1122 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the first documented hospitalisation, up to 42 months

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Unplanned Hospitalisation for Any Cause	1137 participants	1264 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the first documented hospitalisation, up to 42 months.

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Unplanned Hospitalisation for CV Reason	909 participants	1047 participants

SECONDARY outcome

Timeframe: From the date of randomisation to the date of the first event, up to 42 months

CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction

Outcome measures

Measure	Ivabradine n=3241 Participants Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3264 Participants Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Secondary Composite Endpoint	825 participants	979 participants

Adverse Events

Ivabradine

Serious events: 1369 serious events

Other events: 2062 other events

Deaths: 0 deaths

Placebo

Serious events: 1481 serious events

Other events: 2020 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ivabradine n=3232 participants at risk Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3260 participants at risk Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Investigations Pregnancy test positive	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Sleep study	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Transplant evaluation	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Ultrasound Doppler	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Dehydration	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.71% 23/3232 • Number of events 25 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.0% 33/3260 • Number of events 34 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Anaemia	0.19% 6/3232 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.25% 8/3260 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Microcytic anaemia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Nephrogenic anaemia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Spleen disorder	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Acute coronary syndrome	0.28% 9/3232 • Number of events 11 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.43% 14/3260 • Number of events 14 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Acute myocardial infarction	1.9% 62/3232 • Number of events 65 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.7% 54/3260 • Number of events 61 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Adams-Stokes syndrome	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Angina pectoris	1.6% 51/3232 • Number of events 61 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.7% 55/3260 • Number of events 60 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Angina unstable	3.5% 113/3232 • Number of events 140 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	3.7% 119/3260 • Number of events 139 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrial fibrillation	3.9% 126/3232 • Number of events 139 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	3.3% 106/3260 • Number of events 114 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrial flutter	0.68% 22/3232 • Number of events 22 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.58% 19/3260 • Number of events 20 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrial tachycardia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrial thrombosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrioventricular block complete	0.28% 9/3232 • Number of events 9 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrioventricular block first degree	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrioventricular block second degree	0.22% 7/3232 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrioventricular block third degree	0.25% 8/3232 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Bradycardia	0.46% 15/3232 • Number of events 15 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiac aneurysm	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiac arrest	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiac failure	15.7% 506/3232 • Number of events 766 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	20.4% 665/3260 • Number of events 1093 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiac failure acute	0.37% 12/3232 • Number of events 13 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiac failure congestive	0.53% 17/3232 • Number of events 21 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.58% 19/3260 • Number of events 21 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardio-respiratory distress	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiogenic shock	0.46% 15/3232 • Number of events 15 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.49% 16/3260 • Number of events 16 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiomyopathy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Conduction disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Congestive cardiomyopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cor pulmonale	0.03% 1/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Coronary artery disease	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Coronary artery insufficiency	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Coronary artery occlusion	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Coronary artery stenosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Intracardiac thrombus	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ischaemic cardiomyopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Left ventricular failure	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Mitral valve incompetence	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Mitral valve stenosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Myocardial infarction	1.8% 57/3232 • Number of events 63 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.6% 51/3260 • Number of events 51 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Myocardial ischaemia	0.06% 2/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Nodal arrhythmia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Pericardial effusion	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Pericarditis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Rhythm idioventricular	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Sick sinus syndrome	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Sinoatrial block	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Supraventricular extrasystoles	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Supraventricular tachycardia	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Torsade de pointes	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Tricuspid valve incompetence	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular arrhythmia	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular dysfunction	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular extrasystoles	0.46% 15/3232 • Number of events 15 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.28% 9/3260 • Number of events 9 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular fibrillation	0.62% 20/3232 • Number of events 21 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.34% 11/3260 • Number of events 11 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular tachyarrhythmia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular tachycardia	0.96% 31/3232 • Number of events 34 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.4% 46/3260 • Number of events 52 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia haemorrhagic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Ear and labyrinth disorders Vertigo	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Ear and labyrinth disorders Vertigo positional	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Endocrine disorders Goitre	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Endocrine disorders Hyperparathyroidism primary	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Endocrine disorders Hyperthyroidism	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Cataract	0.28% 9/3232 • Number of events 11 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Cataract cortical	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Diabetic retinopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Glaucoma	0.09% 3/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Iridocyclitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Lens dislocation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Open angle glaucoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Presbyopia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Retinal artery embolism	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Retinal artery occlusion	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Retinal detachment	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Retinopathy proliferative	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Ulcerative keratitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Uveitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Vision blurred	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastric haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Vitreous haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Abdominal distension	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Abdominal hernia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Abdominal pain	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Anal fistula	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Ascites	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Colitis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Colonic haematoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Colonic polyp	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Constipation	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Diarrhoea	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Disbacteriosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Diverticulum duodenal	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Diverticulum intestinal	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Duodenitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Dyspepsia	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Dysphagia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Enteritis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Enterocolitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Erosive duodenitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastric polyps	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Femoral hernia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Food poisoning	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastric disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastroduodenitis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastric ulcer	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastric ulcer haemorrhage	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastric ulcer perforation	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastritis	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastritis atrophic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastritis erosive	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastritis haemorrhagic	0.06% 2/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastrointestinal erosion	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastrointestinal perforation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Haemorrhoids	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Hiatus hernia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Ileus	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Inguinal hernia	0.25% 8/3232 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.25% 8/3260 • Number of events 9 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Intestinal ischaemia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Mallory-Weiss syndrome	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Mechanical ileus	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Megacolon	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Melaena	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Mesenteric artery thrombosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Pancreatic cyst	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Pancreatitis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Pancreatitis acute	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Pancreatitis chronic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Peritonitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Polyp colorectal	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Reflux oesophagitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Sigmoiditis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Subileus	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Thrombosis mesenteric vessel	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Umbilical hernia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.19% 6/3232 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Volvulus	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Vomiting	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Accidental death	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Cardiac death	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Chest pain	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Death	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Fatigue	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Hyperthermia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Oedema peripheral	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Pain	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Implant site inflammation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Implant site ulcer	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Non-cardiac chest pain	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Pyrexia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Sudden cardiac death	2.3% 73/3232 • Number of events 73 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.1% 68/3260 • Number of events 68 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Sudden death	3.4% 111/3232 • Number of events 111 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	3.7% 119/3260 • Number of events 119 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
General disorders Systemic inflammatory response syndrome	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Bile duct stone	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Biliary colic	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Biliary dilatation	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Cholangitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Cholecystitis	0.22% 7/3232 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.34% 11/3260 • Number of events 11 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Cholecystitis acute	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.28% 9/3260 • Number of events 9 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Cholelithiasis	0.19% 6/3232 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Cholestasis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Cytolytic hepatitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatic cirrhosis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatic congestion	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatic steatosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatitis cholestatic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatitis toxic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Gastrointestinal infection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hepatorenal failure	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Jaundice	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Hepatobiliary disorders Post cholecystectomy syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Graft infection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Immune system disorders Allergic oedema	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Immune system disorders Anaphylactic shock	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Immune system disorders Cryoglobulinaemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Abdominal sepsis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Abdominal wall abscess	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Abscess limb	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Abscess oral	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Appendicitis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Ascites infection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bacterial sepsis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchiectasis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchitis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchitis acute	0.31% 10/3232 • Number of events 11 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.55% 18/3260 • Number of events 20 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchitis acute viral	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchitis chronic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchopneumonia	0.22% 7/3232 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bursitis infective	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Candida sepsis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Cellulitis	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.18% 6/3260 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Clostridium colitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Device related infection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Diabetic foot infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Diabetic gangrene	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Hepatitis B	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Diverticulitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Ear infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Endocarditis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Epidemic nephropathy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Epstein-Barr virus infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Erysipelas	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Escherichia urinary tract infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Gangrene	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Gastroenteritis	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Gastroenteritis enteroviral	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Gastroenteritis viral	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Hepatitis C	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Herpes zoster	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Infected skin ulcer	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Cardiac electrophysiologic study	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Influenza	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Intervertebral discitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Laryngitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Lobar pneumonia	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Lower respiratory tract infection	0.06% 2/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Lower respiratory tract infection viral	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Lung abscess	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Lung infection	0.12% 4/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Lung infection pseudomonal	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Malaria	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Necrotising fasciitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Obstructive chronic bronchitis with acute exacerbation	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Orchitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Oropharyngeal candidiasis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Osteomyelitis	0.09% 3/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Otitis media chronic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Perianal abscess	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Peritoneal tuberculosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pneumonia	2.2% 70/3232 • Number of events 79 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.0% 65/3260 • Number of events 69 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pneumonia bacterial	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pneumonia klebsiella	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pneumonia primary atypical	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pneumonia staphylococcal	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Post procedural cellulitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Postoperative infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Postoperative wound infection	0.06% 2/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pulmonary sepsis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pulmonary tuberculosis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Purulent synovitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pyelonephritis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pyelonephritis acute	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pyelonephritis chronic	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pyonephrosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Respiratory tract infection	0.22% 7/3232 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Respiratory tract infection bacterial	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Respiratory tract infection viral	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Salmonellosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Sepsis	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Septic shock	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Sinusitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Staphylococcal infection	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Staphylococcal sepsis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Tracheobronchitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Tuberculosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Upper respiratory tract infection	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Urinary tract infection	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Urinary tract infection bacterial	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Urosepsis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Viral infection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Wound infection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Cardiac pacemaker malfunction	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Cerebral haemorrhage traumatic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Chest injury	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Closed head injury	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Device dislocation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Diaphragmatic injury	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Fall	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Femur fracture	0.22% 7/3232 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Fibula fracture	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Haemothorax	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Hand fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Head injury	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Hip fracture	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Humerus fracture	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Implantable defibrillator malfunction	0.19% 6/3232 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Intervertebral disc injury	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Joint injury	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Lower limb fracture	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Multiple drug overdose accidental	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Multiple fractures	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Operative haemorrhage	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Pacemaker complication	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Polytraumatism	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Post procedural complication	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Postoperative hernia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Renal injury	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Rib fracture	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Road traffic accident	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Scrotal haematoma	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Skeletal injury	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Stent occlusion	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Subdural haematoma	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Tracheostomy malfunction	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Traumatic brain injury	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Urinary bladder rupture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Vascular graft occlusion	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Wrist fracture	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Anticoagulation drug level above therapeutic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Arteriogram	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Arteriogram coronary	0.74% 24/3232 • Number of events 24 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.37% 12/3260 • Number of events 13 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Blood chloride decreased	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Blood potassium increased	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Carcinoembryonic antigen increased	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Cardiac pacemaker evaluation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Cardiovascular evaluation	0.84% 27/3232 • Number of events 32 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.83% 27/3260 • Number of events 31 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Catheterisation cardiac	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Coagulation time prolonged	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Colonoscopy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Electrocardiogram abnormal	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Haemoglobin decreased	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Heart rate decreased	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Hysteroscopy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Investigation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Nephrological examination	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus non-insulin-dependent	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetic foot	0.09% 3/3232 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.25% 8/3260 • Number of events 8 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Electrolyte imbalance	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Gout	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hyperkalaemia	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hypoglycaemia	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hypokalaemia	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hypovolaemia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Malnutrition	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Metabolic syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Dactylitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.19% 6/3232 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Monarthritis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.18% 6/3260 • Number of events 6 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Osteochondrosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Osteoporosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Systemic sclerosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign biliary neoplasm	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia recurrent	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell carcinoma of the kidney	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant mediastinal neoplasm	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer stage unspecified	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue carcinoma stage IV	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Brain stem haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Carotid artery occlusion	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Carotid artery stenosis	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cognitive disorder	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebellar haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebellar infarction	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebral arteriosclerosis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebral artery embolism	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebral haematoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebral haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebral infarction	0.22% 7/3232 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.37% 12/3260 • Number of events 13 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebral ischaemia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebrovascular accident	0.43% 14/3232 • Number of events 14 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.49% 16/3260 • Number of events 17 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Cerebrovascular disorder	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Coma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Dementia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Dementia Alzheimer's type	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Depressed level of consciousness	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Diabetic neuropathy	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Dizziness	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Embolic stroke	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Encephalitis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Encephalopathy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Epilepsy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Extrapyramidal disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Facial palsy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Grand mal convulsion	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Haemorrhagic stroke	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Headache	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Hypertensive encephalopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Hypoglycaemic coma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Hypoxic encephalopathy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Intracranial aneurysm	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Intracranial haematoma	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Ischaemic cerebral infarction	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Ischaemic stroke	1.1% 34/3232 • Number of events 37 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.4% 46/3260 • Number of events 48 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Lacunar infarction	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Loss of consciousness	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Metabolic encephalopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Migraine with aura	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Neuropathy peripheral	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Paraesthesia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Polyneuropathy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Sciatica	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Spinal cord haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Subarachnoid haemorrhage	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Syncope	0.37% 12/3232 • Number of events 12 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.61% 20/3260 • Number of events 21 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Syncope vasovagal	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Tarsal tunnel syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Transient ischaemic attack	0.34% 11/3232 • Number of events 12 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.37% 12/3260 • Number of events 12 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Vascular dementia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Vascular encephalopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Vertebrobasilar insufficiency	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Pregnancy, puerperium and perinatal conditions Pregnancy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Affective disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Aggression	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Alcoholism	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Anxiety	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Anxiety disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Completed suicide	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Delirium	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Depression	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Disturbance in social behaviour	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Schizophreniform disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Psychiatric disorders Suicide attempt	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Acute prerenal failure	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Anuria	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Calculus ureteric	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Calculus urinary	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Diabetic nephropathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Glomerulonephritis chronic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Nephrolithiasis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Nephropathy toxic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Nephrotic syndrome	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Polyuria	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal artery stenosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal colic	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal failure	0.43% 14/3232 • Number of events 14 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.43% 14/3260 • Number of events 14 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal failure acute	0.34% 11/3232 • Number of events 13 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal failure chronic	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal impairment	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Stress incontinence	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Urethral stenosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Urinary retention	0.03% 1/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Endometrial hyperplasia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Metrorrhagia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Ovarian cyst	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Phimosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.62% 20/3232 • Number of events 25 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.77% 25/3260 • Number of events 31 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 2/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 12 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchial hyperactivity	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 35/3232 • Number of events 53 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.0% 33/3260 • Number of events 50 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Diaphragmatic hernia	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Dyspnoea exacerbated	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Haemopneumothorax	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Nasal cyst	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Non-cardiogenic pulmonary oedema	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.25% 8/3232 • Number of events 9 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.71% 23/3260 • Number of events 24 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Dry gangrene	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Psoriasis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Skin ulcer	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Social circumstances Social stay hospitalisation	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Alcohol detoxification	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Arrhythmia prophylaxis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Arterial bypass operation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cardiac ablation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cardiac aneurysm repair	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cardiac pacemaker insertion	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cardiac rehabilitation therapy	0.22% 7/3232 • Number of events 9 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 10 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cardiac resynchronisation therapy	0.62% 20/3232 • Number of events 21 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.89% 29/3260 • Number of events 30 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Carotid endarterectomy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cataract operation	0.03% 1/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Cholecystectomy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Coronary angioplasty	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Coronary arterial stent insertion	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Coronary artery surgery	0.37% 12/3232 • Number of events 12 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Coronary revascularisation	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Diabetes mellitus management	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Ear operation	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Eventration procedure	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Gastric banding	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Heart transplant	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Hip arthroplasty	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Implantable defibrillator insertion	0.53% 17/3232 • Number of events 17 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.64% 21/3260 • Number of events 21 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Implantable defibrillator replacement	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Incisional hernia repair	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Inguinal hernia repair	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Knee arthroplasty	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Knee operation	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Mitral valve replacement	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Obesity surgery	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Percutaneous coronary intervention	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Physiotherapy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Rehabilitation therapy	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Renal tumour excision	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Tooth extraction	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Transurethral prostatectomy	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Ureteral stent removal	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Surgical and medical procedures Weight loss diet	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Aortic aneurysm	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Aortic aneurysm rupture	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Aortic dissection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Aortic stenosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Arterial thrombosis limb	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.12% 4/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Arteriosclerosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Arteriosclerosis obliterans	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.09% 3/3260 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Bleeding varicose vein	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Blood pressure inadequately controlled	0.53% 17/3232 • Number of events 19 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.40% 13/3260 • Number of events 13 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Deep vein thrombosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.21% 7/3260 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Diabetic macroangiopathy	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Diabetic vascular disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Extremity necrosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Femoral artery aneurysm	0.03% 1/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Femoral artery dissection	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Femoral artery occlusion	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Haematoma	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Hypertension	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Hypertensive crisis	0.15% 5/3232 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Hypertensive emergency	0.06% 2/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Hypotension	0.09% 3/3232 • Number of events 3 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 5 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Iliac artery embolism	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Iliac artery occlusion	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Iliac artery thrombosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Intermittent claudication	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Lymphoedema	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Orthostatic hypotension	0.12% 4/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Peripheral arterial occlusive disease	0.46% 15/3232 • Number of events 15 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.46% 15/3260 • Number of events 18 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Peripheral artery aneurysm	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Peripheral embolism	0.09% 3/3232 • Number of events 4 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Peripheral ischaemia	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.15% 5/3260 • Number of events 7 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Peripheral vascular disorder	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Subclavian artery stenosis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Thrombophlebitis	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Thrombophlebitis superficial	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.06% 2/3260 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Thrombosis	0.00% 0/3232 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Varicose vein	0.03% 1/3232 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.03% 1/3260 • Number of events 1 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Venous thrombosis limb	0.06% 2/3232 • Number of events 2 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.00% 0/3260 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).

Other adverse events

Measure	Ivabradine n=3232 participants at risk Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.	Placebo n=3260 participants at risk Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
Blood and lymphatic system disorders Anaemia	2.8% 91/3232 • Number of events 93 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.8% 92/3260 • Number of events 96 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Angina pectoris	2.6% 85/3232 • Number of events 97 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.9% 93/3260 • Number of events 109 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrial fibrillation	5.0% 161/3232 • Number of events 176 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	3.8% 123/3260 • Number of events 138 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Atrioventricular block first degree	1.1% 35/3232 • Number of events 38 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.1% 36/3260 • Number of events 42 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Bradycardia	4.1% 134/3232 • Number of events 142 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.80% 26/3260 • Number of events 30 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Cardiac failure	8.9% 289/3232 • Number of events 337 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	9.2% 299/3260 • Number of events 369 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Sinus tachycardia	1.2% 40/3232 • Number of events 45 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	3.1% 102/3260 • Number of events 115 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Supraventricular extrasystoles	1.2% 39/3232 • Number of events 41 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.5% 49/3260 • Number of events 50 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular extrasystoles	4.0% 129/3232 • Number of events 140 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	4.0% 131/3260 • Number of events 137 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Cardiac disorders Ventricular tachycardia	1.1% 34/3232 • Number of events 37 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.80% 26/3260 • Number of events 28 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Eye disorders Phosphenes	2.8% 89/3232 • Number of events 95 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.49% 16/3260 • Number of events 18 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Gastrointestinal disorders Gastritis	1.1% 34/3232 • Number of events 34 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.1% 36/3260 • Number of events 36 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchitis	1.2% 38/3232 • Number of events 44 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.0% 34/3260 • Number of events 40 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Bronchitis acute	1.8% 59/3232 • Number of events 64 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.1% 68/3260 • Number of events 79 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Influenza	2.0% 66/3232 • Number of events 74 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.1% 68/3260 • Number of events 76 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Nasopharyngitis	2.0% 66/3232 • Number of events 70 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.1% 70/3260 • Number of events 85 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Pneumonia	1.7% 56/3232 • Number of events 60 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.1% 69/3260 • Number of events 78 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Respiratory tract infection	1.2% 39/3232 • Number of events 40 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	0.77% 25/3260 • Number of events 28 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Respiratory tract infection viral	0.93% 30/3232 • Number of events 33 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.0% 34/3260 • Number of events 36 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Upper respiratory tract infection	1.0% 33/3232 • Number of events 35 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.6% 52/3260 • Number of events 55 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Infections and infestations Urinary tract infection	0.74% 24/3232 • Number of events 24 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.1% 37/3260 • Number of events 40 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Injury, poisoning and procedural complications Fall	1.1% 36/3232 • Number of events 40 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.3% 42/3260 • Number of events 47 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Blood creatinine increased	1.7% 55/3232 • Number of events 58 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.4% 47/3260 • Number of events 49 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Heart rate decreased	5.5% 178/3232 • Number of events 193 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.4% 45/3260 • Number of events 46 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Investigations Transaminases increased	1.4% 46/3232 • Number of events 48 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.3% 42/3260 • Number of events 42 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus	0.99% 32/3232 • Number of events 32 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.1% 35/3260 • Number of events 35 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	3.6% 116/3232 • Number of events 125 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	3.5% 115/3260 • Number of events 125 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hypercholesterolaemia	1.0% 33/3232 • Number of events 33 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.0% 34/3260 • Number of events 34 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hyperkalaemia	0.84% 27/3232 • Number of events 29 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.6% 53/3260 • Number of events 56 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Metabolism and nutrition disorders Hyperuricaemia	1.5% 47/3232 • Number of events 47 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.6% 52/3260 • Number of events 52 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.74% 24/3232 • Number of events 24 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.2% 40/3260 • Number of events 42 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Dizziness	1.7% 55/3232 • Number of events 62 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.4% 45/3260 • Number of events 50 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Nervous system disorders Headache	1.3% 43/3232 • Number of events 45 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.8% 58/3260 • Number of events 67 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal failure	1.5% 50/3232 • Number of events 53 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.1% 69/3260 • Number of events 71 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Renal and urinary disorders Renal failure chronic	0.84% 27/3232 • Number of events 28 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.4% 45/3260 • Number of events 45 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 37/3232 • Number of events 42 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.7% 55/3260 • Number of events 68 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Respiratory, thoracic and mediastinal disorders Cough	1.3% 42/3232 • Number of events 44 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	1.3% 44/3260 • Number of events 44 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Blood pressure inadequately controlled	6.7% 216/3232 • Number of events 259 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	5.8% 188/3260 • Number of events 215 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).
Vascular disorders Hypotension	1.8% 59/3232 • Number of events 62 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).	2.5% 82/3260 • Number of events 91 • From randomisation to death, up to 42 months The Randomised Set consisted of 6505 patients (3241 patients in the ivabradine group and 3264 patients in the placebo group). The Safety Set consisted of 6492 patients: 13 randomised patients were excluded from the Safety Set because they did not take any study drug (9 patients in the ivabradine group and 4 patients in the placebo group).

Additional Information

Therapeutic Innovation Pole

Institut de Recherches Internationales Servier (I.R.I.S.)

Phone: +33155724366

Email: clinicaltrials@servier.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review publication and/or communication related to the study results and can require changes. In case of a patent application, the sponsor can delay its authorization for publication or communication of the study results until the date of international registration of the patent.
• Publication restrictions are in place

Restriction type: OTHER